Serious adverse events
|
DB-Apixaban |
OL-Apixaban |
DB-ASA |
Total subjects affected by serious adverse events
|
|
|
|
subjects affected / exposed
|
679 / 2798 (24.27%) |
1252 / 3275 (38.23%) |
844 / 2780 (30.36%) |
number of deaths (all causes)
|
111 |
265 |
140 |
number of deaths resulting from adverse events
|
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
Acute myeloid leukaemia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma gastric
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adrenal adenoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Angiosarcoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
B-Cell lymphoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
B-Cell small lymphocytic lymphoma stage iv
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
|
subjects affected / exposed
|
5 / 2798 (0.18%) |
12 / 3275 (0.37%) |
5 / 2780 (0.18%) |
occurrences causally related to treatment / all
|
1 / 6 |
1 / 12 |
3 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Basosquamous carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Biliary neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
4 / 3275 (0.12%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder cancer stage 0, with cancer in situ
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bowen's disease
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain cancer metastatic
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Brain neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
4 / 3275 (0.12%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain neoplasm benign
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast cancer
|
|
|
|
subjects affected / exposed
|
9 / 2798 (0.32%) |
10 / 3275 (0.31%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
3 / 9 |
5 / 10 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Breast cancer metastatic
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Carcinoid tumour of the caecum
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carcinoid tumour of the pancreas
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervix carcinoma stage 0
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholangiocarcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Cholesteatoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic lymphocytic leukaemia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
6 / 3275 (0.18%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 6 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Colon cancer metastatic
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colon neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colorectal cancer
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diffuse large b-cell lymphoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial cancer
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gallbladder cancer
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
Gastric cancer
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
3 / 3275 (0.09%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 3 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Gastrointestinal carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal stromal tumour
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic neoplasm malignant
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Hepatocellular carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal adenocarcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intraductal papillary mucinous neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intraocular melanoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Invasive ductal breast carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Laryngeal cancer
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Leiomyoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Leiomyosarcoma metastatic
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Leukaemia
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Light chain disease
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Lip and/or oral cavity cancer
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lipoma
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Liposarcoma
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung adenocarcinoma metastatic
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung cancer metastatic
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Lung neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Lung neoplasm malignant
|
|
|
|
subjects affected / exposed
|
4 / 2798 (0.14%) |
17 / 3275 (0.52%) |
5 / 2780 (0.18%) |
occurrences causally related to treatment / all
|
1 / 4 |
8 / 18 |
2 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Lymph node cancer metastatic
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lymphoma
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malignant melanoma stage i
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meningioma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Metastases to abdominal cavity
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to bone
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to central nervous system
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to liver
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to pleura
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastatic neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Metastatic renal cell carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myeloproliferative neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neoplasm malignant
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Neoplasm prostate
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neuroendocrine tumour
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma stage iii
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal adenocarcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal cancer metastatic
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Omentum neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian cancer
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
3 / 3275 (0.09%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
6 / 3275 (0.18%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 7 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Paraneoplastic syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pituitary tumour benign
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
|
subjects affected / exposed
|
7 / 2798 (0.25%) |
13 / 3275 (0.40%) |
12 / 2780 (0.43%) |
occurrences causally related to treatment / all
|
2 / 7 |
6 / 14 |
2 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Prostate cancer metastatic
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer recurrent
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic adenoma
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
3 / 3275 (0.09%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal cancer
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
Rectal cancer metastatic
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal cancer stage ii
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal cancer stage iii
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal cell carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sebaceous carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Seborrhoeic keratosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin cancer
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
3 / 3275 (0.09%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
7 / 3275 (0.21%) |
4 / 2780 (0.14%) |
occurrences causally related to treatment / all
|
4 / 5 |
2 / 8 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of skin
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
4 / 3275 (0.12%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
2 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the cervix
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Throat cancer
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thyroid adenoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tonsil cancer
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transitional cell carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tumour haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ureteric cancer metastatic
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine cancer
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vocal cord neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
Accelerated hypertension
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aneurysm
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic aneurysm
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Aortic dissection
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic rupture
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Aortic stenosis
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
3 / 3275 (0.09%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arterial disorder
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arterial occlusive disease
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arterial stenosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arterial thrombosis limb
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis obliterans
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
3 / 3275 (0.09%) |
6 / 2780 (0.22%) |
occurrences causally related to treatment / all
|
1 / 2 |
2 / 3 |
3 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dry gangrene
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femoral artery embolism
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femoral artery occlusion
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematoma
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
5 / 3275 (0.15%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
1 / 1 |
3 / 5 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
6 / 3275 (0.18%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
1 / 1 |
5 / 6 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertension
|
|
|
|
subjects affected / exposed
|
4 / 2798 (0.14%) |
13 / 3275 (0.40%) |
9 / 2780 (0.32%) |
occurrences causally related to treatment / all
|
3 / 4 |
4 / 13 |
4 / 10 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 2 |
0 / 0 |
Hypertensive crisis
|
|
|
|
subjects affected / exposed
|
6 / 2798 (0.21%) |
3 / 3275 (0.09%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
1 / 6 |
1 / 4 |
3 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypotension
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
5 / 3275 (0.15%) |
5 / 2780 (0.18%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 6 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypovolaemic shock
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Intermittent claudication
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Leriche syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lymphocele
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malignant hypertension
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
3 / 3275 (0.09%) |
6 / 2780 (0.22%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 3 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pallor
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic venous thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
4 / 2780 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral embolism
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
3 / 3275 (0.09%) |
5 / 2780 (0.18%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral vascular disorder
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral venous disease
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Phlebitis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Shock
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 0 |
Subclavian artery stenosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Temporal arteritis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombophlebitis superficial
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Varicose ulceration
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Varicose vein
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Varicose vein ruptured
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Venous haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Venous insufficiency
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
|
Abdominoplasty
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Angioplasty
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anorectal operation
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic aneurysm repair
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve replacement
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Appendicectomy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign tumour excision
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder polypectomy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bursa removal
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bursal operation
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cancer surgery
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac ablation
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
1 / 3275 (0.03%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac pacemaker battery replacement
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac pacemaker insertion
|
|
|
|
subjects affected / exposed
|
4 / 2798 (0.14%) |
9 / 3275 (0.27%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 9 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac pacemaker removal
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac pacemaker replacement
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardioversion
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carotid endarterectomy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cataract operation
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chemotherapy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystectomy
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Choledochoenterostomy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary angioplasty
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary arterial stent insertion
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery bypass
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endarterectomy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endovenous ablation
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Explorative laparotomy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eye operation
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fasciotomy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gallbladder operation
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric bypass
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal tube insertion
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Genitourinary operation
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoid operation
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Heart valve operation
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Heart valve replacement
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hernia repair
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
High frequency ablation
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hip arthroplasty
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
9 / 3275 (0.27%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 9 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hip surgery
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hospitalisation
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
1 / 3275 (0.03%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hydronephrosis repair
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hysterectomy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Implantable defibrillator insertion
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Implantable defibrillator replacement
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incisional hernia repair
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia repair
|
|
|
|
subjects affected / exposed
|
4 / 2798 (0.14%) |
4 / 3275 (0.12%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal anastomosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Knee arthroplasty
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
6 / 3275 (0.18%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Knee operation
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Laparotomy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lithotripsy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Liver operation
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung operation
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mastectomy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Medical device implantation
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Medical device removal
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve repair
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve replacement
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Orchidectomy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreaticoduodenectomy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Papilloma excision
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Percutaneous coronary intervention
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery angioplasty
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
3 / 3275 (0.09%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Plastic surgery to the face
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Proctocolectomy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic operation
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal polypectomy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rehabilitation therapy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal stone removal
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Salivary gland operation
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin graft
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin lesion removal
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin neoplasm excision
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal fusion surgery
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tarsal tunnel decompression
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Therapeutic embolisation
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thromboembolectomy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thyroid operation
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thyroidectomy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Toe amputation
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tooth extraction
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tracheostomy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transfusion
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transurethral prostatectomy
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
4 / 2780 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ureteral stent insertion
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urethral stent insertion
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine dilation and curettage
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular graft
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventriculo-Peritoneal shunt
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vertebroplasty
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Weight loss diet
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wrist surgery
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pregnancy, puerperium and perinatal conditions
|
|
|
|
Cephalhaematoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
Adverse drug reaction
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
3 / 3275 (0.09%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Asthenia
|
|
|
|
subjects affected / exposed
|
4 / 2798 (0.14%) |
9 / 3275 (0.27%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
1 / 4 |
2 / 9 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac death
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
3 / 3275 (0.09%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
1 / 3 |
1 / 1 |
Chest discomfort
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chest pain
|
|
|
|
subjects affected / exposed
|
18 / 2798 (0.64%) |
29 / 3275 (0.89%) |
27 / 2780 (0.97%) |
occurrences causally related to treatment / all
|
5 / 26 |
5 / 31 |
9 / 33 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Death
|
|
|
|
subjects affected / exposed
|
20 / 2798 (0.71%) |
48 / 3275 (1.47%) |
16 / 2780 (0.58%) |
occurrences causally related to treatment / all
|
9 / 20 |
17 / 48 |
5 / 16 |
deaths causally related to treatment / all
|
7 / 17 |
15 / 45 |
4 / 15 |
Device lead damage
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device malfunction
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device pacing issue
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Exercise tolerance decreased
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fatigue
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
|
subjects affected / exposed
|
4 / 2798 (0.14%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Generalised oedema
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Hernia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hernia pain
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Implant site effusion
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated hernia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malaise
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Medical device complication
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Multi-Organ failure
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
5 / 3275 (0.15%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Non-Cardiac chest pain
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
2 / 3275 (0.06%) |
6 / 2780 (0.22%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oedema
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
7 / 3275 (0.21%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 7 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pain
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic mass
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral swelling
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
7 / 3275 (0.21%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sudden cardiac death
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
6 / 3275 (0.18%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
1 / 3 |
3 / 6 |
1 / 1 |
deaths causally related to treatment / all
|
1 / 3 |
3 / 6 |
1 / 1 |
Sudden death
|
|
|
|
subjects affected / exposed
|
13 / 2798 (0.46%) |
36 / 3275 (1.10%) |
15 / 2780 (0.54%) |
occurrences causally related to treatment / all
|
4 / 13 |
8 / 36 |
5 / 15 |
deaths causally related to treatment / all
|
3 / 12 |
7 / 33 |
5 / 15 |
Suprapubic pain
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Swelling
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Systemic inflammatory response syndrome
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Unevaluable event
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
Anaphylactic reaction
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Social circumstances
|
|
|
|
Activities of daily living impaired
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac assistance device user
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Physical assault
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
Benign prostatic hyperplasia
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
8 / 3275 (0.24%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 8 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast mass
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Menometrorrhagia
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metrorrhagia
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postmenopausal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic hypoplasia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic obstruction
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatomegaly
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spermatic cord disorder
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine polyp
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vaginal haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
Acute pulmonary oedema
|
|
|
|
subjects affected / exposed
|
6 / 2798 (0.21%) |
4 / 3275 (0.12%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
1 / 6 |
1 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
Acute respiratory distress syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute respiratory failure
|
|
|
|
subjects affected / exposed
|
5 / 2798 (0.18%) |
4 / 3275 (0.12%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
1 / 5 |
1 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Allergic bronchitis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Asphyxia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Asthma
|
|
|
|
subjects affected / exposed
|
6 / 2798 (0.21%) |
5 / 3275 (0.15%) |
4 / 2780 (0.14%) |
occurrences causally related to treatment / all
|
3 / 6 |
1 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Atelectasis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis chronic
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
|
subjects affected / exposed
|
12 / 2798 (0.43%) |
25 / 3275 (0.76%) |
11 / 2780 (0.40%) |
occurrences causally related to treatment / all
|
2 / 12 |
9 / 37 |
3 / 17 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
Cough
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
|
subjects affected / exposed
|
13 / 2798 (0.46%) |
24 / 3275 (0.73%) |
13 / 2780 (0.47%) |
occurrences causally related to treatment / all
|
11 / 18 |
3 / 28 |
3 / 13 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 0 |
Dyspnoea exertional
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
4 / 3275 (0.12%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Emphysema
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
|
subjects affected / exposed
|
5 / 2798 (0.18%) |
16 / 3275 (0.49%) |
6 / 2780 (0.22%) |
occurrences causally related to treatment / all
|
4 / 5 |
14 / 17 |
6 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
6 / 3275 (0.18%) |
4 / 2780 (0.14%) |
occurrences causally related to treatment / all
|
3 / 3 |
6 / 7 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Haemothorax
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hiccups
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperventilation
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung consolidation
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
3 / 3275 (0.09%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Lung infiltration
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mediastinal mass
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Orthopnoea
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
6 / 3275 (0.18%) |
4 / 2780 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pleurisy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
3 / 3275 (0.09%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
1 / 3 |
1 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Pneumothorax
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary artery thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary congestion
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
|
subjects affected / exposed
|
4 / 2798 (0.14%) |
9 / 3275 (0.27%) |
12 / 2780 (0.43%) |
occurrences causally related to treatment / all
|
0 / 4 |
3 / 9 |
3 / 12 |
deaths causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 0 |
Pulmonary fibrosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary hypertension
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
4 / 3275 (0.12%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary vascular disorder
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory arrest
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Respiratory distress
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
3 / 3275 (0.09%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Respiratory failure
|
|
|
|
subjects affected / exposed
|
4 / 2798 (0.14%) |
5 / 3275 (0.15%) |
12 / 2780 (0.43%) |
occurrences causally related to treatment / all
|
2 / 4 |
1 / 6 |
2 / 12 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
2 / 7 |
Sinus polyp
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sleep apnoea syndrome
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
Adjustment disorder
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Alcohol abuse
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Alcohol withdrawal syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anxiety
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bipolar disorder
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bipolar i disorder
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
Confusional state
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Delirium
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Depression
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
3 / 3275 (0.09%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 3 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hallucination
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Insomnia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mental disorder
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Panic attack
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Paranoia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Psychotic disorder
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Stress
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Suicidal ideation
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Suicide attempt
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Product issues
|
|
|
|
Lead dislodgement
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
Acute hepatic failure
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct stenosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct stone
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
3 / 3275 (0.09%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
3 / 3275 (0.09%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
3 / 3 |
1 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholangitis acute
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Cholecystitis
|
|
|
|
subjects affected / exposed
|
6 / 2798 (0.21%) |
4 / 3275 (0.12%) |
7 / 2780 (0.25%) |
occurrences causally related to treatment / all
|
2 / 6 |
0 / 5 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
|
subjects affected / exposed
|
5 / 2798 (0.18%) |
4 / 3275 (0.12%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
3 / 5 |
1 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Cholecystitis chronic
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
7 / 3275 (0.21%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
2 / 3 |
2 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholestasis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic cirrhosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Hepatic cyst
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic failure
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis fulminant
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatomegaly
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperbilirubinaemia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Jaundice cholestatic
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Liver disorder
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Portal hypertension
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Investigations
|
|
|
|
Angiogram
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriogram coronary
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthroscopy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood magnesium decreased
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colonoscopy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cystoscopy
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ecg signs of myocardial ischaemia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ejection fraction decreased
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemoglobin decreased
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Heart rate abnormal
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Heart rate irregular
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Liver function test abnormal
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Liver function test increased
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Platelet count decreased
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic specific antigen increased
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Red blood cell sedimentation rate increased
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Weight decreased
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
Abdominal wound dehiscence
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Accidental overdose
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Animal bite
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
3 / 3275 (0.09%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic injury
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Brain contusion
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral haemorrhage traumatic
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervical vertebral fracture
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chest injury
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Concussion
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Confusion postoperative
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Contusion
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Drug toxicity
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eschar
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fall
|
|
|
|
subjects affected / exposed
|
4 / 2798 (0.14%) |
13 / 3275 (0.40%) |
7 / 2780 (0.25%) |
occurrences causally related to treatment / all
|
3 / 4 |
2 / 15 |
2 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
8 / 3275 (0.24%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
3 / 8 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
|
subjects affected / exposed
|
5 / 2798 (0.18%) |
11 / 3275 (0.34%) |
7 / 2780 (0.25%) |
occurrences causally related to treatment / all
|
1 / 5 |
2 / 12 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fractured sacrum
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hand fracture
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Head injury
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
|
subjects affected / exposed
|
5 / 2798 (0.18%) |
12 / 3275 (0.37%) |
7 / 2780 (0.25%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 12 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
In-Stent arterial restenosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
In-Stent coronary artery restenosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated incisional hernia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
3 / 3275 (0.09%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Injury
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Jaw fracture
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Laceration
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
3 / 3275 (0.09%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ligament sprain
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Limb traumatic amputation
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
8 / 3275 (0.24%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meniscus lesion
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Multiple fractures
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Multiple injuries
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Muscle rupture
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Muscle strain
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Overdose
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
3 / 3275 (0.09%) |
5 / 2780 (0.18%) |
occurrences causally related to treatment / all
|
2 / 4 |
0 / 3 |
2 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Patella fracture
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Periorbital haematoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural bile leak
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural diarrhoea
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural fistula
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haematuria
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Procedural haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Procedural pain
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pubis fracture
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Scapula fracture
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skull fracture
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
Spinal column injury
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Stomal hernia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
|
subjects affected / exposed
|
4 / 2798 (0.14%) |
5 / 3275 (0.15%) |
4 / 2780 (0.14%) |
occurrences causally related to treatment / all
|
3 / 5 |
4 / 5 |
2 / 4 |
deaths causally related to treatment / all
|
1 / 1 |
1 / 1 |
1 / 1 |
Tendon rupture
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Therapeutic agent toxicity
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
3 / 3275 (0.09%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
5 / 3275 (0.15%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic brain injury
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic haematoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ulna fracture
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
4 / 3275 (0.12%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound evisceration
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound secretion
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
|
Atrial septal defect
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Congenital cystic kidney disease
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal arteriovenous malformation
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Liddle's syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
Acute coronary syndrome
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
7 / 3275 (0.21%) |
6 / 2780 (0.22%) |
occurrences causally related to treatment / all
|
1 / 3 |
2 / 7 |
2 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute left ventricular failure
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Acute myocardial infarction
|
|
|
|
subjects affected / exposed
|
13 / 2798 (0.46%) |
25 / 3275 (0.76%) |
19 / 2780 (0.68%) |
occurrences causally related to treatment / all
|
3 / 13 |
11 / 27 |
6 / 21 |
deaths causally related to treatment / all
|
1 / 3 |
2 / 6 |
2 / 5 |
Angina pectoris
|
|
|
|
subjects affected / exposed
|
5 / 2798 (0.18%) |
15 / 3275 (0.46%) |
9 / 2780 (0.32%) |
occurrences causally related to treatment / all
|
0 / 5 |
4 / 15 |
2 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
|
subjects affected / exposed
|
21 / 2798 (0.75%) |
17 / 3275 (0.52%) |
12 / 2780 (0.43%) |
occurrences causally related to treatment / all
|
9 / 23 |
4 / 17 |
6 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
Aortic valve incompetence
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve stenosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
4 / 3275 (0.12%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
Arrhythmia supraventricular
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
|
subjects affected / exposed
|
77 / 2798 (2.75%) |
114 / 3275 (3.48%) |
71 / 2780 (2.55%) |
occurrences causally related to treatment / all
|
17 / 89 |
37 / 169 |
24 / 94 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 2 |
1 / 1 |
Atrial flutter
|
|
|
|
subjects affected / exposed
|
7 / 2798 (0.25%) |
8 / 3275 (0.24%) |
6 / 2780 (0.22%) |
occurrences causally related to treatment / all
|
4 / 8 |
3 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrial tachycardia
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
2 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
3 / 3275 (0.09%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block complete
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
1 / 3275 (0.03%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bradyarrhythmia
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
3 / 3275 (0.09%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
|
subjects affected / exposed
|
6 / 2798 (0.21%) |
11 / 3275 (0.34%) |
5 / 2780 (0.18%) |
occurrences causally related to treatment / all
|
1 / 6 |
1 / 11 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
|
subjects affected / exposed
|
4 / 2798 (0.14%) |
12 / 3275 (0.37%) |
9 / 2780 (0.32%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 12 |
4 / 9 |
deaths causally related to treatment / all
|
1 / 2 |
0 / 8 |
3 / 7 |
Cardiac asthma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorder
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure
|
|
|
|
subjects affected / exposed
|
70 / 2798 (2.50%) |
120 / 3275 (3.66%) |
79 / 2780 (2.84%) |
occurrences causally related to treatment / all
|
11 / 84 |
31 / 179 |
23 / 95 |
deaths causally related to treatment / all
|
0 / 4 |
2 / 13 |
1 / 3 |
Cardiac failure acute
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
3 / 3275 (0.09%) |
7 / 2780 (0.25%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 3 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 3 |
0 / 0 |
Cardiac failure chronic
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
7 / 3275 (0.21%) |
4 / 2780 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 7 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 2 |
Cardiac failure congestive
|
|
|
|
subjects affected / exposed
|
46 / 2798 (1.64%) |
55 / 3275 (1.68%) |
36 / 2780 (1.29%) |
occurrences causally related to treatment / all
|
17 / 66 |
26 / 73 |
9 / 42 |
deaths causally related to treatment / all
|
1 / 5 |
3 / 8 |
0 / 0 |
Cardio-Respiratory arrest
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
9 / 3275 (0.27%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
2 / 9 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
2 / 7 |
0 / 2 |
Cardiogenic shock
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
5 / 3275 (0.15%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
1 / 3 |
0 / 0 |
Cardiomyopathy
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiopulmonary failure
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
5 / 3275 (0.15%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 2 |
Cardiovascular insufficiency
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Carditis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Conduction disorder
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Congestive cardiomyopathy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
3 / 3275 (0.09%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
Cor pulmonale
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
|
subjects affected / exposed
|
4 / 2798 (0.14%) |
16 / 3275 (0.49%) |
7 / 2780 (0.25%) |
occurrences causally related to treatment / all
|
0 / 5 |
9 / 18 |
2 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
Coronary artery insufficiency
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Coronary artery occlusion
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Defect conduction intraventricular
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Heart valve incompetence
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive heart disease
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intracardiac thrombus
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
0 / 3275 (0.00%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic cardiomyopathy
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
3 / 3275 (0.09%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 3 |
0 / 0 |
Left ventricular dysfunction
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
3 / 3275 (0.09%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Left ventricular failure
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
7 / 3275 (0.21%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
4 / 7 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Microvascular angina
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve disease
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
5 / 3275 (0.15%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 6 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve prolapse
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve stenosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
4 / 3275 (0.12%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
|
subjects affected / exposed
|
14 / 2798 (0.50%) |
25 / 3275 (0.76%) |
14 / 2780 (0.50%) |
occurrences causally related to treatment / all
|
4 / 14 |
5 / 25 |
6 / 14 |
deaths causally related to treatment / all
|
1 / 4 |
0 / 8 |
2 / 3 |
Myocardial ischaemia
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
4 / 3275 (0.12%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 4 |
1 / 3 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 0 |
Nodal arrhythmia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nodal rhythm
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Palpitations
|
|
|
|
subjects affected / exposed
|
4 / 2798 (0.14%) |
2 / 3275 (0.06%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
3 / 5 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pericarditis constrictive
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pleuropericarditis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prinzmetal angina
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rheumatic heart disease
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Right ventricular failure
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sick sinus syndrome
|
|
|
|
subjects affected / exposed
|
9 / 2798 (0.32%) |
0 / 3275 (0.00%) |
14 / 2780 (0.50%) |
occurrences causally related to treatment / all
|
1 / 10 |
0 / 0 |
1 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinoatrial block
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinus arrest
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinus arrhythmia
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinus node dysfunction
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
18 / 3275 (0.55%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
4 / 19 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
1 / 3275 (0.03%) |
6 / 2780 (0.22%) |
occurrences causally related to treatment / all
|
3 / 5 |
0 / 1 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tachyarrhythmia
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
2 / 3275 (0.06%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tricuspid valve incompetence
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular arrhythmia
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
4 / 3275 (0.12%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Ventricular extrasystoles
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular failure
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Ventricular fibrillation
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
3 / 3275 (0.09%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
Ventricular tachycardia
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
4 / 3275 (0.12%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 4 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Nervous system disorders
|
|
|
|
Altered state of consciousness
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Aphasia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Autonomic nervous system imbalance
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Balance disorder
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Basal ganglia haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain stem haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
Brain stem infarction
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carotid arterial embolus
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
4 / 3275 (0.12%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebellar ataxia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebellar infarction
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral artery embolism
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral cyst
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral haematoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
10 / 3275 (0.31%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
3 / 3 |
8 / 10 |
1 / 1 |
deaths causally related to treatment / all
|
2 / 2 |
1 / 3 |
1 / 1 |
Cerebral infarction
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
10 / 3275 (0.31%) |
7 / 2780 (0.25%) |
occurrences causally related to treatment / all
|
0 / 2 |
7 / 12 |
2 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Cerebral microhaemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
|
subjects affected / exposed
|
17 / 2798 (0.61%) |
16 / 3275 (0.49%) |
44 / 2780 (1.58%) |
occurrences causally related to treatment / all
|
6 / 17 |
4 / 19 |
14 / 45 |
deaths causally related to treatment / all
|
2 / 4 |
0 / 3 |
0 / 2 |
Cerebrovascular disorder
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular insufficiency
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervical root pain
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cognitive disorder
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Coma
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Convulsion
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cubital tunnel syndrome
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dementia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dementia alzheimer's type
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Dementia with lewy bodies
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Depressed level of consciousness
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Diabetic hyperglycaemic coma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic neuropathy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dizziness
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
6 / 3275 (0.18%) |
10 / 2780 (0.36%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 6 |
4 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dysarthria
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dyskinesia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Embolic stroke
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
3 / 3275 (0.09%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 3 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Encephalopathy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
|
subjects affected / exposed
|
4 / 2798 (0.14%) |
4 / 3275 (0.12%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
1 / 4 |
2 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic cerebral infarction
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic stroke
|
|
|
|
subjects affected / exposed
|
5 / 2798 (0.18%) |
8 / 3275 (0.24%) |
8 / 2780 (0.29%) |
occurrences causally related to treatment / all
|
4 / 5 |
7 / 8 |
6 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
3 / 4 |
0 / 0 |
Headache
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hydrocephalus
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoaesthesia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemic coma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyponatraemic encephalopathy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intraventricular haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic cerebral infarction
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
|
subjects affected / exposed
|
24 / 2798 (0.86%) |
26 / 3275 (0.79%) |
51 / 2780 (1.83%) |
occurrences causally related to treatment / all
|
11 / 27 |
7 / 27 |
27 / 55 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
1 / 3 |
Lacunar infarction
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lethargy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar radiculopathy
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Migraine
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myoclonus
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neuritis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neuroglycopenia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Paraesthesia
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Paraplegia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Parkinson's disease
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
4 / 3275 (0.12%) |
4 / 2780 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
4 / 7 |
2 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Partial seizures
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral nerve palsy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post-Traumatic epilepsy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Presyncope
|
|
|
|
subjects affected / exposed
|
5 / 2798 (0.18%) |
4 / 3275 (0.12%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
1 / 5 |
1 / 4 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sciatica
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Seizure
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
3 / 3275 (0.09%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Simple partial seizures
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Status epilepticus
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
Subdural effusion
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Syncope
|
|
|
|
subjects affected / exposed
|
8 / 2798 (0.29%) |
26 / 3275 (0.79%) |
21 / 2780 (0.76%) |
occurrences causally related to treatment / all
|
2 / 8 |
4 / 27 |
4 / 22 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombotic stroke
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
|
subjects affected / exposed
|
10 / 2798 (0.36%) |
13 / 3275 (0.40%) |
30 / 2780 (1.08%) |
occurrences causally related to treatment / all
|
3 / 10 |
3 / 13 |
14 / 33 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tremor
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uraemic encephalopathy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular dementia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular encephalopathy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vertebrobasilar insufficiency
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Viith nerve paralysis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
Anaemia
|
|
|
|
subjects affected / exposed
|
12 / 2798 (0.43%) |
24 / 3275 (0.73%) |
11 / 2780 (0.40%) |
occurrences causally related to treatment / all
|
11 / 18 |
18 / 26 |
7 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anaemia megaloblastic
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aplastic anaemia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Coagulopathy
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemolytic anaemia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic diathesis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Iron deficiency anaemia
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
3 / 3275 (0.09%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
2 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Leukopenia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lymphadenopathy
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
|
Ear disorder
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ear haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
5 / 3275 (0.15%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
Amaurosis fugax
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cataract
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
6 / 3275 (0.18%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diplopia
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eye haemorrhage
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eye pain
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eyelid ptosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Keratitis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinal artery embolism
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinal artery occlusion
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tolosa-Hunt syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vitreous haemorrhage
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
Abdominal adhesions
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal distension
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal hernia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal mass
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
|
subjects affected / exposed
|
5 / 2798 (0.18%) |
6 / 3275 (0.18%) |
5 / 2780 (0.18%) |
occurrences causally related to treatment / all
|
3 / 6 |
1 / 6 |
2 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal strangulated hernia
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal wall haematoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute abdomen
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal fistula
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ascites
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
3 / 3275 (0.09%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Barrett's oesophagus
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic gastritis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colitis ulcerative
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colonic polyp
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Constipation
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
6 / 3275 (0.18%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 7 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
11 / 3275 (0.34%) |
5 / 2780 (0.18%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 11 |
2 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Diverticulum
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum intestinal
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
3 / 3275 (0.09%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer perforation
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Duodenitis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Faecaloma
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Food poisoning
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric disorder
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
4 / 3275 (0.12%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
3 / 4 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis
|
|
|
|
subjects affected / exposed
|
5 / 2798 (0.18%) |
3 / 3275 (0.09%) |
6 / 2780 (0.22%) |
occurrences causally related to treatment / all
|
2 / 5 |
0 / 3 |
3 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 2 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis haemorrhagic
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroduodenitis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorder
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
4 / 2798 (0.14%) |
20 / 3275 (0.61%) |
11 / 2780 (0.40%) |
occurrences causally related to treatment / all
|
3 / 4 |
19 / 20 |
7 / 11 |
deaths causally related to treatment / all
|
2 / 2 |
1 / 1 |
1 / 1 |
Gastrointestinal hypomotility
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal perforation
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gingival bleeding
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
4 / 3275 (0.12%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Haematochezia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
3 / 3275 (0.09%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
3 / 3275 (0.09%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ileus
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ileus paralytic
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated umbilical hernia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
12 / 3275 (0.37%) |
6 / 2780 (0.22%) |
occurrences causally related to treatment / all
|
0 / 3 |
2 / 12 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia strangulated
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal ischaemia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
6 / 3275 (0.18%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal ulcer
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Large intestinal obstruction
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
3 / 3275 (0.09%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar hernia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mallory-Weiss syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Melaena
|
|
|
|
subjects affected / exposed
|
5 / 2798 (0.18%) |
5 / 3275 (0.15%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
5 / 5 |
6 / 6 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mesenteric artery embolism
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mesenteric artery thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mouth haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nausea
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal achalasia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal dilatation
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal stenosis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal varices haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
2 / 3275 (0.06%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
3 / 3275 (0.09%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis chronic
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peptic ulcer
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Proctitis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Proctitis ulcerative
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
|
subjects affected / exposed
|
8 / 2798 (0.29%) |
8 / 3275 (0.24%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
7 / 10 |
8 / 8 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Reflux oesophagitis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retroperitoneal haematoma
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spigelian hernia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Splenic artery aneurysm
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subileus
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tooth loss
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
15 / 3275 (0.46%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
12 / 16 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Volvulus
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vomiting
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
1 / 2 |
3 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
Angioedema
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood blister
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Decubitus ulcer
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dermatitis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dermatitis herpetiformis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic foot
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
3 / 3275 (0.09%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Erythema
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Purpura
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rash erythematous
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin lesion
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
3 / 3275 (0.09%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
Acute kidney injury
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
25 / 3275 (0.76%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
8 / 28 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
Azotaemia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder mass
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Calculus bladder
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Calculus ureteric
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Calculus urethral
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Calculus urinary
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
3 / 3275 (0.09%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Cystitis haemorrhagic
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic nephropathy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dysuria
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematuria
|
|
|
|
subjects affected / exposed
|
5 / 2798 (0.18%) |
13 / 3275 (0.40%) |
6 / 2780 (0.22%) |
occurrences causally related to treatment / all
|
6 / 6 |
9 / 14 |
3 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage urinary tract
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive nephropathy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postrenal failure
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal colic
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal cyst
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal failure
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
7 / 3275 (0.21%) |
7 / 2780 (0.25%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 7 |
2 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 1 |
Renal failure acute
|
|
|
|
subjects affected / exposed
|
9 / 2798 (0.32%) |
0 / 3275 (0.00%) |
10 / 2780 (0.36%) |
occurrences causally related to treatment / all
|
7 / 12 |
0 / 0 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal failure chronic
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal infarct
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal tubular necrosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urethral disorder
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary incontinence
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
2 / 3275 (0.06%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
|
Goitre
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperparathyroidism
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperthyroidism
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
4 / 3275 (0.12%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypothyroidism
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thyroid haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thyroid mass
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
Arthralgia
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Back pain
|
|
|
|
subjects affected / exposed
|
7 / 2798 (0.25%) |
9 / 3275 (0.27%) |
4 / 2780 (0.14%) |
occurrences causally related to treatment / all
|
2 / 7 |
0 / 9 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bursitis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gouty arthritis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemarthrosis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal mass
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc degeneration
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
4 / 3275 (0.12%) |
4 / 2780 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Joint swelling
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
4 / 3275 (0.12%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Muscle haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Muscle spasms
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
3 / 3275 (0.09%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal stiffness
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myalgia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myopathy
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
|
subjects affected / exposed
|
11 / 2798 (0.39%) |
19 / 3275 (0.58%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
1 / 11 |
4 / 20 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteochondrosis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteopenia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Plantar fasciitis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Polyarthritis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Polymyalgia rheumatica
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
3 / 3275 (0.09%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rheumatoid arthritis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal column stenosis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
4 / 3275 (0.12%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal pain
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Systemic lupus erythematosus
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tendon pain
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
Abdominal wall abscess
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal wall infection
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abscess
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Amoebic dysentery
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
6 / 3275 (0.18%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Arthritis bacterial
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
|
subjects affected / exposed
|
7 / 2798 (0.25%) |
15 / 3275 (0.46%) |
7 / 2780 (0.25%) |
occurrences causally related to treatment / all
|
1 / 7 |
3 / 16 |
2 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Bronchopneumonia
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
0 / 3275 (0.00%) |
5 / 2780 (0.18%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
3 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
Cellulitis
|
|
|
|
subjects affected / exposed
|
7 / 2798 (0.25%) |
13 / 3275 (0.40%) |
5 / 2780 (0.18%) |
occurrences causally related to treatment / all
|
1 / 7 |
3 / 15 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic sinusitis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium colitis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
Colonic abscess
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dengue fever
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic foot infection
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Disseminated tuberculosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
7 / 3275 (0.21%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulitis intestinal haemorrhagic
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Empyema
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Encephalitis viral
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
3 / 3275 (0.09%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endophthalmitis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
8 / 3275 (0.24%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 8 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia bacteraemia
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia infection
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gangrene
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
|
subjects affected / exposed
|
8 / 2798 (0.29%) |
15 / 3275 (0.46%) |
5 / 2780 (0.18%) |
occurrences causally related to treatment / all
|
0 / 8 |
3 / 17 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis salmonella
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
3 / 3275 (0.09%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal infection
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Groin infection
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Helicobacter gastritis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Helicobacter infection
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic amoebiasis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis c
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis e
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
3 / 3275 (0.09%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 3 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Implant site infection
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infection
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infectious pleural effusion
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infective exacerbation of chronic obstructive airways disease
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Influenza
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Klebsiella bacteraemia
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Listeriosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Liver abscess
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lobar pneumonia
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Localised infection
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
5 / 3275 (0.15%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 6 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
Lung infection
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meningitis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nasopharyngitis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nosocomial infection
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal candidiasis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ophthalmic herpes zoster
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oral candidiasis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Orchitis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Periorbital cellulitis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
|
subjects affected / exposed
|
42 / 2798 (1.50%) |
104 / 3275 (3.18%) |
61 / 2780 (2.19%) |
occurrences causally related to treatment / all
|
6 / 45 |
23 / 120 |
14 / 69 |
deaths causally related to treatment / all
|
1 / 5 |
2 / 8 |
0 / 2 |
Pneumonia escherichia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia influenzal
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia klebsiella
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia pneumococcal
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia primary atypical
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Pneumonia streptococcal
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia viral
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative abscess
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostate infection
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Psoas abscess
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary sepsis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary tuberculosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Pyelonephritis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
1 / 3275 (0.03%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyometra
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
6 / 3275 (0.18%) |
5 / 2780 (0.18%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sepsis
|
|
|
|
subjects affected / exposed
|
4 / 2798 (0.14%) |
18 / 3275 (0.55%) |
4 / 2780 (0.14%) |
occurrences causally related to treatment / all
|
1 / 4 |
3 / 19 |
2 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
2 / 5 |
0 / 0 |
Sepsis syndrome
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Septic shock
|
|
|
|
subjects affected / exposed
|
4 / 2798 (0.14%) |
14 / 3275 (0.43%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
1 / 4 |
2 / 14 |
0 / 2 |
deaths causally related to treatment / all
|
1 / 2 |
0 / 5 |
0 / 1 |
Sinusitis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin infection
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Soft tissue infection
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Staphylococcal bacteraemia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal infection
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
Tracheitis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tracheobronchitis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tuberculosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tuberculous pleurisy
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
3 / 3275 (0.09%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
|
subjects affected / exposed
|
13 / 2798 (0.46%) |
24 / 3275 (0.73%) |
16 / 2780 (0.58%) |
occurrences causally related to treatment / all
|
1 / 14 |
3 / 26 |
3 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
Urinary tract infection bacterial
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection enterococcal
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
4 / 3275 (0.12%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vestibular neuronitis
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Viral infection
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Viral upper respiratory tract infection
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound infection
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
Cachexia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Calciphylaxis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Decreased appetite
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dehydration
|
|
|
|
subjects affected / exposed
|
9 / 2798 (0.32%) |
11 / 3275 (0.34%) |
7 / 2780 (0.25%) |
occurrences causally related to treatment / all
|
1 / 9 |
1 / 13 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
|
subjects affected / exposed
|
5 / 2798 (0.18%) |
7 / 3275 (0.21%) |
4 / 2780 (0.14%) |
occurrences causally related to treatment / all
|
1 / 5 |
2 / 7 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetes mellitus inadequate control
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
3 / 3275 (0.09%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetes with hyperosmolarity
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Electrolyte imbalance
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gout
|
|
|
|
subjects affected / exposed
|
2 / 2798 (0.07%) |
1 / 3275 (0.03%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
|
subjects affected / exposed
|
3 / 2798 (0.11%) |
2 / 3275 (0.06%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
5 / 3275 (0.15%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypernatraemia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoalbuminaemia
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
|
subjects affected / exposed
|
8 / 2798 (0.29%) |
12 / 3275 (0.37%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
2 / 10 |
3 / 15 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
2 / 3275 (0.06%) |
3 / 2780 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypomagnesaemia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
|
subjects affected / exposed
|
4 / 2798 (0.14%) |
6 / 3275 (0.18%) |
4 / 2780 (0.14%) |
occurrences causally related to treatment / all
|
5 / 7 |
2 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypophosphataemia
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lactic acidosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
0 / 3275 (0.00%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolic acidosis
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Obesity
|
|
|
|
subjects affected / exposed
|
0 / 2798 (0.00%) |
1 / 3275 (0.03%) |
1 / 2780 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Starvation
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
0 / 3275 (0.00%) |
0 / 2780 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
|
subjects affected / exposed
|
1 / 2798 (0.04%) |
2 / 3275 (0.06%) |
2 / 2780 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |