Serious adverse events
|
Sotagliflozin |
Placebo |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
1236 / 5291 (23.36%) |
1331 / 5286 (25.18%) |
number of deaths (all causes)
|
246 |
246 |
number of deaths resulting from adverse events
|
173 |
192 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Acute leukaemia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute lymphocytic leukaemia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Adenocarcinoma gastric
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Adenocarcinoma of colon
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
B-cell lymphoma
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign laryngeal neoplasm
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign lung neoplasm
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of urethra
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign renal neoplasm
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Bladder cancer recurrent
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma recurrent
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma stage 0
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bowen's disease
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain neoplasm
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Breast cancer
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
5 / 5286 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Breast cancer stage III
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Burkitt's lymphoma stage IV
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cancer pain
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervix carcinoma
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chloroma
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangiocarcinoma
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 4 |
Chronic lymphocytic leukaemia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic myeloid leukaemia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clear cell renal cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
subjects affected / exposed
|
6 / 5291 (0.11%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Colon cancer stage 0
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal cancer metastatic
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ear neoplasm
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial cancer
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
External ear neoplasm malignant
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal stromal tumour
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glioblastoma
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Glioma
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatocellular carcinoma
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hodgkin's disease
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive breast carcinoma
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive ductal breast carcinoma
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive lobular breast carcinoma
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Keratoacanthoma
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal cancer
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lentigo maligna
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lipoma
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liposarcoma
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lung carcinoma cell type unspecified stage IV
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung neoplasm
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung neoplasm malignant
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lung squamous cell carcinoma stage III
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma in situ
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant neoplasm of unknown primary site
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Malignant pleural effusion
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningioma benign
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to liver
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastases to lung
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastases to peritoneum
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastatic malignant melanoma
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastatic renal cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastatic uterine cancer
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Nasopharyngeal neoplasm benign
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroendocrine tumour of the lung metastatic
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Non-Hodgkin's lymphoma
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Oesophageal carcinoma
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Oropharyngeal cancer stage II
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian adenoma
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic carcinoma
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
5 / 5286 (0.09%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 4 |
Pancreatic carcinoma metastatic
|
|
|
subjects affected / exposed
|
5 / 5291 (0.09%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 0 |
Pancreatic neoplasm
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Papillary serous endometrial carcinoma
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papillary thyroid cancer
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parathyroid tumour benign
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
subjects affected / exposed
|
10 / 5291 (0.19%) |
13 / 5286 (0.25%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer stage IV
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic adenoma
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cancer stage IV
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cell carcinoma
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal neoplasm
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland cancer
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seborrhoeic keratosis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin cancer
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of lung
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of skin
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Testis cancer
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transitional cell carcinoma
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine cancer
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain oedema
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Vascular disorders
|
|
|
Accelerated hypertension
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic dissection
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic stenosis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial haemorrhage
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
6 / 5291 (0.11%) |
15 / 5286 (0.28%) |
occurrences causally related to treatment / all
|
0 / 7 |
3 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Diabetic vascular disorder
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dry gangrene
|
|
|
subjects affected / exposed
|
6 / 5291 (0.11%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Essential hypertension
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extremity necrosis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral artery aneurysm
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertension
|
|
|
subjects affected / exposed
|
8 / 5291 (0.15%) |
13 / 5286 (0.25%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
subjects affected / exposed
|
7 / 5291 (0.13%) |
13 / 5286 (0.25%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive urgency
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotension
|
|
|
subjects affected / exposed
|
5 / 5291 (0.09%) |
7 / 5286 (0.13%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemic shock
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iliac artery occlusion
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intermittent claudication
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Internal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leriche syndrome
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphoedema
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
1 / 3 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic venous thrombosis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
subjects affected / exposed
|
16 / 5291 (0.30%) |
15 / 5286 (0.28%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery aneurysm
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
subjects affected / exposed
|
5 / 5291 (0.09%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Peripheral embolism
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
subjects affected / exposed
|
8 / 5291 (0.15%) |
5 / 5286 (0.09%) |
occurrences causally related to treatment / all
|
2 / 8 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral vascular disorder
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shock haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Subclavian steal syndrome
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis superficial
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose ulceration
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose vein
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vasculitis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
Aortic aneurysm repair
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve replacement
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac pacemaker replacement
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystectomy
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary angioplasty
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot amputation
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hysterectomy
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraocular lens implant
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Knee arthroplasty
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Knee operation
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve replacement
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrectomy
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Percutaneous coronary intervention
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
Asthenia
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac death
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Chest pain
|
|
|
subjects affected / exposed
|
7 / 5291 (0.13%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic fatigue syndrome
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Death
|
|
|
subjects affected / exposed
|
9 / 5291 (0.17%) |
12 / 5286 (0.23%) |
occurrences causally related to treatment / all
|
1 / 9 |
0 / 12 |
deaths causally related to treatment / all
|
1 / 9 |
0 / 12 |
Fatigue
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised oedema
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza like illness
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device site discharge
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device site haematoma
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Necrobiosis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
10 / 5291 (0.19%) |
12 / 5286 (0.23%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral swelling
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
subjects affected / exposed
|
5 / 5291 (0.09%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Soft tissue inflammation
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden cardiac death
|
|
|
subjects affected / exposed
|
14 / 5291 (0.26%) |
8 / 5286 (0.15%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 14 |
0 / 8 |
Sudden death
|
|
|
subjects affected / exposed
|
7 / 5291 (0.13%) |
5 / 5286 (0.09%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 5 |
Systemic inflammatory response syndrome
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent stenosis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
Anaphylactic reaction
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Acquired hydrocele
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adnexa uteri cyst
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Balanoposthitis
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign prostatic hyperplasia
|
|
|
subjects affected / exposed
|
7 / 5291 (0.13%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast pain
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial hyperplasia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postmenopausal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatomegaly
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Testicular torsion
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine haemorrhage
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine polyp
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal prolapse
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulval disorder
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Acute pulmonary oedema
|
|
|
subjects affected / exposed
|
9 / 5291 (0.17%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Acute respiratory distress syndrome
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Acute respiratory failure
|
|
|
subjects affected / exposed
|
11 / 5291 (0.21%) |
12 / 5286 (0.23%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Aspiration
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthma
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atelectasis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchial hyperreactivity
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis chronic
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
9 / 5291 (0.17%) |
19 / 5286 (0.36%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Chronic respiratory disease
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic respiratory failure
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
subjects affected / exposed
|
9 / 5291 (0.17%) |
10 / 5286 (0.19%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Dyspnoea exertional
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrothorax
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nocturnal dyspnoea
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pickwickian syndrome
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleurisy
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleuritic pain
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Pneumonitis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary congestion
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
7 / 5291 (0.13%) |
13 / 5286 (0.25%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Pulmonary fibrosis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary hypertension
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary mass
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
8 / 5286 (0.15%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory arrest
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory depression
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
subjects affected / exposed
|
8 / 5291 (0.15%) |
8 / 5286 (0.15%) |
occurrences causally related to treatment / all
|
0 / 8 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Sleep apnoea syndrome
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Acute stress disorder
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol abuse
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bipolar disorder
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Confusional state
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Conversion disorder
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delirium
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hallucination
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicidal ideation
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product issues
|
|
|
Device breakage
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device dislocation
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device failure
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device loosening
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device malfunction
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device occlusion
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Alanine aminotransferase increased
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood bilirubin increased
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood glucose decreased
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood glucose increased
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
5 / 5286 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure increased
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain natriuretic peptide increased
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
C-reactive protein increased
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheterisation cardiac
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ECG signs of myocardial ischaemia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram PR prolongation
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterococcus test positive
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glomerular filtration rate decreased
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glycosylated haemoglobin increased
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoglobin decreased
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
International normalised ratio increased
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Klebsiella test positive
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver function test increased
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SARS-CoV-2 test positive
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Transaminases increased
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Troponin increased
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
Accidental overdose
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Airway burns
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia postoperative
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anastomotic ulcer haemorrhage
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
subjects affected / exposed
|
7 / 5291 (0.13%) |
7 / 5286 (0.13%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone contusion
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain contusion
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Burns second degree
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon injury
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Contusion
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dural tear
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
subjects affected / exposed
|
22 / 5291 (0.42%) |
13 / 5286 (0.25%) |
occurrences causally related to treatment / all
|
1 / 24 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Femoral neck fracture
|
|
|
subjects affected / exposed
|
5 / 5291 (0.09%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
subjects affected / exposed
|
7 / 5291 (0.13%) |
7 / 5286 (0.13%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
subjects affected / exposed
|
12 / 5291 (0.23%) |
15 / 5286 (0.28%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Forearm fracture
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fractured sacrum
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hand fracture
|
|
|
subjects affected / exposed
|
7 / 5291 (0.13%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head injury
|
|
|
subjects affected / exposed
|
7 / 5291 (0.13%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hip fracture
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
5 / 5286 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
subjects affected / exposed
|
14 / 5291 (0.26%) |
16 / 5286 (0.30%) |
occurrences causally related to treatment / all
|
1 / 14 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated parastomal hernia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaw fracture
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint injury
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb crushing injury
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb fracture
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb injury
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Meniscus injury
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple fractures
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple injuries
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Patella fracture
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periprocedural myocardial infarction
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematuria
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative ileus
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative respiratory failure
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative thoracic procedure complication
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural pain
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural shock
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiation pneumonitis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
subjects affected / exposed
|
7 / 5291 (0.13%) |
8 / 5286 (0.15%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
subjects affected / exposed
|
13 / 5291 (0.25%) |
9 / 5286 (0.17%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
5 / 5286 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Scratch
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin abrasion
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin laceration
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Snake bite
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stab wound
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sternal fracture
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stomal hernia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous haematoma
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Tendon rupture
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
subjects affected / exposed
|
5 / 5291 (0.09%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic haematoma
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic haemothorax
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic intracranial haematoma
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulna fracture
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
subjects affected / exposed
|
6 / 5291 (0.11%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft occlusion
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound necrosis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
subjects affected / exposed
|
7 / 5291 (0.13%) |
5 / 5286 (0.09%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Acute coronary syndrome
|
|
|
subjects affected / exposed
|
7 / 5291 (0.13%) |
8 / 5286 (0.15%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Acute left ventricular failure
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
6 / 5286 (0.11%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute myocardial infarction
|
|
|
subjects affected / exposed
|
48 / 5291 (0.91%) |
59 / 5286 (1.12%) |
occurrences causally related to treatment / all
|
1 / 50 |
1 / 67 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 9 |
Acute right ventricular failure
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
subjects affected / exposed
|
18 / 5291 (0.34%) |
25 / 5286 (0.47%) |
occurrences causally related to treatment / all
|
1 / 18 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Angina unstable
|
|
|
subjects affected / exposed
|
44 / 5291 (0.83%) |
52 / 5286 (0.98%) |
occurrences causally related to treatment / all
|
1 / 47 |
0 / 58 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve sclerosis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve stenosis
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Arrhythmia
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Arteriosclerosis coronary artery
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
34 / 5291 (0.64%) |
35 / 5286 (0.66%) |
occurrences causally related to treatment / all
|
0 / 42 |
1 / 36 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
subjects affected / exposed
|
6 / 5291 (0.11%) |
12 / 5286 (0.23%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial tachycardia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block complete
|
|
|
subjects affected / exposed
|
5 / 5291 (0.09%) |
14 / 5286 (0.26%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Atrioventricular block second degree
|
|
|
subjects affected / exposed
|
5 / 5291 (0.09%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bifascicular block
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
7 / 5291 (0.13%) |
7 / 5286 (0.13%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bundle branch block
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac aneurysm
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
subjects affected / exposed
|
5 / 5291 (0.09%) |
11 / 5286 (0.21%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 11 |
Cardiac disorder
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiac failure
|
|
|
subjects affected / exposed
|
94 / 5291 (1.78%) |
147 / 5286 (2.78%) |
occurrences causally related to treatment / all
|
0 / 107 |
2 / 183 |
deaths causally related to treatment / all
|
0 / 15 |
0 / 19 |
Cardiac failure acute
|
|
|
subjects affected / exposed
|
18 / 5291 (0.34%) |
28 / 5286 (0.53%) |
occurrences causally related to treatment / all
|
0 / 19 |
1 / 32 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 7 |
Cardiac failure chronic
|
|
|
subjects affected / exposed
|
9 / 5291 (0.17%) |
27 / 5286 (0.51%) |
occurrences causally related to treatment / all
|
0 / 10 |
1 / 32 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Cardiac failure congestive
|
|
|
subjects affected / exposed
|
23 / 5291 (0.43%) |
46 / 5286 (0.87%) |
occurrences causally related to treatment / all
|
0 / 27 |
2 / 54 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 6 |
Cardiac tamponade
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
subjects affected / exposed
|
6 / 5291 (0.11%) |
7 / 5286 (0.13%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 7 |
Cardiogenic shock
|
|
|
subjects affected / exposed
|
6 / 5291 (0.11%) |
5 / 5286 (0.09%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 4 |
Cardiohepatic syndrome
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiopulmonary failure
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiovascular insufficiency
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Chronic left ventricular failure
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congestive cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
subjects affected / exposed
|
15 / 5291 (0.28%) |
22 / 5286 (0.42%) |
occurrences causally related to treatment / all
|
0 / 15 |
1 / 22 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Coronary artery insufficiency
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery occlusion
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery perforation
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
subjects affected / exposed
|
5 / 5291 (0.09%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart valve incompetence
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive heart disease
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left ventricular dysfunction
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left ventricular failure
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
5 / 5286 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Microvascular coronary artery disease
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
subjects affected / exposed
|
24 / 5291 (0.45%) |
55 / 5286 (1.04%) |
occurrences causally related to treatment / all
|
1 / 25 |
0 / 57 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 22 |
Myocardial ischaemia
|
|
|
subjects affected / exposed
|
6 / 5291 (0.11%) |
7 / 5286 (0.13%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nodal arrhythmia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nodal rhythm
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Palpitations
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial haemorrhage
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prosthetic cardiac valve thrombosis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulseless electrical activity
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Right ventricular failure
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus node dysfunction
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
6 / 5286 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subendocardial ischaemia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tricuspid valve incompetence
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular arrhythmia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular extrasystoles
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular fibrillation
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Ventricular flutter
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular tachycardia
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
Amnesia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aphasia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ataxia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Auditory nerve disorder
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Autonomic neuropathy
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Balance disorder
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal ganglia haemorrhage
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Brain injury
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Brain stem infarction
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain stem ischaemia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cauda equina syndrome
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar stroke
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Cerebral infarction
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
6 / 5286 (0.11%) |
occurrences causally related to treatment / all
|
1 / 4 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cerebral ischaemia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cerebrospinal fluid leakage
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
subjects affected / exposed
|
13 / 5291 (0.25%) |
16 / 5286 (0.30%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
Cerebrovascular disorder
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular insufficiency
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical radiculopathy
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervicobrachial syndrome
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depressed level of consciousness
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic encephalopathy
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic hyperosmolar coma
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic neuropathy
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Disturbance in attention
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysarthria
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyskinesia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial paralysis
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Haemorrhagic stroke
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
8 / 5286 (0.15%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 5 |
Haemorrhagic transformation stroke
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Headache
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiplegia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic encephalopathy
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hypoglycaemic coma
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic unconsciousness
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intercostal neuralgia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
subjects affected / exposed
|
29 / 5291 (0.55%) |
36 / 5286 (0.68%) |
occurrences causally related to treatment / all
|
0 / 29 |
0 / 39 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 7 |
Lacunar infarction
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lacunar stroke
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lumbosacral radiculopathy
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Migraine
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelopathy
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve compression
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parkinson's disease
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parkinsonism
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post stroke seizure
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Presyncope
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiculopathy
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ruptured cerebral aneurysm
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Sacral radiculopathy
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sciatica
|
|
|
subjects affected / exposed
|
5 / 5291 (0.09%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seizure
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Somnolence
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Status epilepticus
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Syncope
|
|
|
subjects affected / exposed
|
26 / 5291 (0.49%) |
27 / 5286 (0.51%) |
occurrences causally related to treatment / all
|
2 / 28 |
1 / 29 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tension headache
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombotic cerebral infarction
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic encephalopathy
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
subjects affected / exposed
|
6 / 5291 (0.11%) |
14 / 5286 (0.26%) |
occurrences causally related to treatment / all
|
0 / 6 |
1 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular encephalopathy
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral artery stenosis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebrobasilar insufficiency
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebrobasilar stroke
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Abdominal lymphadenopathy
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia
|
|
|
subjects affected / exposed
|
6 / 5291 (0.11%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Anaemia macrocytic
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia of chronic disease
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia of malignant disease
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Antiphospholipid syndrome
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Blood loss anaemia
|
|
|
subjects affected / exposed
|
6 / 5291 (0.11%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heparin-induced thrombocytopenia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypochromic anaemia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoprothrombinaemia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Iron deficiency anaemia
|
|
|
subjects affected / exposed
|
6 / 5291 (0.11%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenitis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrogenic anaemia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normochromic normocytic anaemia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normocytic anaemia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic infarction
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
Vertigo
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
6 / 5286 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular disorder
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Amaurosis fugax
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angle closure glaucoma
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract
|
|
|
subjects affected / exposed
|
5 / 5291 (0.09%) |
5 / 5286 (0.09%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Corneal degeneration
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatochalasis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic retinopathy
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diplopia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye haemorrhage
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eyelid cyst
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glaucoma
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular fibrosis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papilloedema
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal artery occlusion
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal ischaemia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual impairment
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous haemorrhage
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Abdominal adhesions
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal hernia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
6 / 5286 (0.11%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Abdominal pain lower
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Constipation
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gastroparesis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
5 / 5286 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal perforation
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenitis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erosive duodenitis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Faecaloma
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Food poisoning
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric haemorrhage
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric polyps
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal angiodysplasia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
5 / 5291 (0.09%) |
5 / 5286 (0.09%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gastrointestinal polyp haemorrhage
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
subjects affected / exposed
|
5 / 5291 (0.09%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrooesophageal sphincter insufficiency
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematochezia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ileus paralytic
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated inguinal hernia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia strangulated
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal infarction
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Intestinal ischaemia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intra-abdominal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Irritable bowel syndrome
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melaena
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric arterial occlusion
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric vein thrombosis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nausea
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive pancreatitis
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal stent stenosis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic cyst
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pancreatitis acute
|
|
|
subjects affected / exposed
|
5 / 5291 (0.09%) |
12 / 5286 (0.23%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Pancreatitis chronic
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Peptic ulcer
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Portal hypertensive gastropathy
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Proctitis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Small intestinal obstruction
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal perforation
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Strangulated umbilical hernia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Vomiting
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
6 / 5286 (0.11%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Acute hepatic failure
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcoholic liver disease
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct obstruction
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct stenosis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct stone
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary colic
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis acute
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
5 / 5286 (0.09%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cholecystitis acute
|
|
|
subjects affected / exposed
|
10 / 5291 (0.19%) |
10 / 5286 (0.19%) |
occurrences causally related to treatment / all
|
0 / 10 |
1 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cholecystitis chronic
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
5 / 5291 (0.09%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholestasis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug-induced liver injury
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder obstruction
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder rupture
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cirrhosis
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic failure
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatic function abnormal
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis acute
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis alcoholic
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatorenal syndrome
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocholecystis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperbilirubinaemia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaundice cholestatic
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumobilia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Angioedema
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blister
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cutaneous loxoscelism
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decubitus ulcer
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermal cyst
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis allergic
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis atopic
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis bullous
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis contact
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot
|
|
|
subjects affected / exposed
|
14 / 5291 (0.26%) |
9 / 5286 (0.17%) |
occurrences causally related to treatment / all
|
0 / 16 |
1 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ulcer
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Drug eruption
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eczema
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypersensitivity vasculitis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic skin ulcer
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrobiosis lipoidica diabeticorum
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathic ulcer
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema blister
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psoriasis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin necrosis
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
subjects affected / exposed
|
12 / 5291 (0.23%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 4 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 1 |
Urticaria
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
Acute kidney injury
|
|
|
subjects affected / exposed
|
61 / 5291 (1.15%) |
52 / 5286 (0.98%) |
occurrences causally related to treatment / all
|
8 / 64 |
11 / 57 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
Anuria
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Calculus bladder
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus urinary
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
subjects affected / exposed
|
14 / 5291 (0.26%) |
18 / 5286 (0.34%) |
occurrences causally related to treatment / all
|
3 / 15 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Cystitis glandularis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic end stage renal disease
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Diabetic nephropathy
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Dysuria
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
End stage renal disease
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eosinophilic cystitis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glomerulonephritis chronic
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Haematuria
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive nephropathy
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
8 / 5286 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephropathy toxic
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrotic syndrome
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
5 / 5286 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive nephropathy
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prerenal failure
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery stenosis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal colic
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal disorder
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure
|
|
|
subjects affected / exposed
|
11 / 5291 (0.21%) |
16 / 5286 (0.30%) |
occurrences causally related to treatment / all
|
2 / 12 |
6 / 17 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Renal haematoma
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal hypertension
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
subjects affected / exposed
|
12 / 5291 (0.23%) |
14 / 5286 (0.26%) |
occurrences causally related to treatment / all
|
1 / 12 |
3 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 4 |
Renal tubular necrosis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Stag horn calculus
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress urinary incontinence
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tubulointerstitial nephritis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric obstruction
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric stenosis
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureterolithiasis
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary incontinence
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Empty sella syndrome
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperparathyroidism
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hyperparathyroidism primary
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Secondary adrenocortical insufficiency
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Arthralgia
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back pain
|
|
|
subjects affected / exposed
|
5 / 5291 (0.09%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical spinal stenosis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Crowned dens syndrome
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Flank pain
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot deformity
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gouty arthritis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gouty tophus
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma muscle
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc disorder
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
7 / 5291 (0.13%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mobility decreased
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myalgia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neck pain
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathic arthropathy
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteitis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
subjects affected / exposed
|
9 / 5291 (0.17%) |
12 / 5286 (0.23%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteochondrosis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoporotic fracture
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pathological fracture
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periarthritis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyarthritis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polymyalgia rheumatica
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psoriatic arthropathy
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rheumatoid arthritis
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal pain
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal stenosis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Abdominal abscess
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall abscess
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
subjects affected / exposed
|
5 / 5291 (0.09%) |
5 / 5286 (0.09%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess neck
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acarodermatitis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute endocarditis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute sinusitis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atypical pneumonia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial colitis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial parotitis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial pyelonephritis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bacterial sepsis
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
7 / 5286 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis bacterial
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
5 / 5286 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bronchitis viral
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COVID-19
|
|
|
subjects affected / exposed
|
5 / 5291 (0.09%) |
6 / 5286 (0.11%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 3 |
COVID-19 pneumonia
|
|
|
subjects affected / exposed
|
6 / 5291 (0.11%) |
5 / 5286 (0.09%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 2 |
Campylobacter colitis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
subjects affected / exposed
|
22 / 5291 (0.42%) |
17 / 5286 (0.32%) |
occurrences causally related to treatment / all
|
1 / 23 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cellulitis of male external genital organ
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis staphylococcal
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis infective
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic hepatitis B
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cryptosporidiosis infection
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cutaneous leishmaniasis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis
|
|
|
subjects affected / exposed
|
6 / 5291 (0.11%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis bacterial
|
|
|
subjects affected / exposed
|
7 / 5291 (0.13%) |
8 / 5286 (0.15%) |
occurrences causally related to treatment / all
|
3 / 7 |
2 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis escherichia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis klebsiella
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cytomegalovirus colitis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dengue haemorrhagic fever
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermo-hypodermitis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot infection
|
|
|
subjects affected / exposed
|
9 / 5291 (0.17%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
1 / 10 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Diabetic gangrene
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
subjects affected / exposed
|
5 / 5291 (0.09%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysentery
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
subjects affected / exposed
|
6 / 5291 (0.11%) |
10 / 5286 (0.19%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia infection
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
1 / 3 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fournier's gangrene
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fungaemia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gangrene
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
8 / 5286 (0.15%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
18 / 5291 (0.34%) |
10 / 5286 (0.19%) |
occurrences causally related to treatment / all
|
1 / 18 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis bacterial
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis clostridial
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis norovirus
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis salmonella
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gastroenteritis viral
|
|
|
subjects affected / exposed
|
5 / 5291 (0.09%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Genital abscess
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin abscess
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin infection
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Helicobacter gastritis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impetigo
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected cyst
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected skin ulcer
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infectious pleural effusion
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective exacerbation of chronic obstructive airways disease
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
7 / 5286 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injection site abscess
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal fistula infection
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Keratitis bacterial
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Klebsiella bacteraemia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Klebsiella sepsis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Liver abscess
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Localised infection
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower respiratory tract infection bacterial
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower respiratory tract infection viral
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ludwig angina
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mastitis bacterial
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mastoiditis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device site infection
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningoencephalitis bacterial
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metapneumovirus infection
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocarditis infectious
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Necrotising fasciitis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Nephritis bacterial
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ophthalmic herpes simplex
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orchitis
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
subjects affected / exposed
|
9 / 5291 (0.17%) |
8 / 5286 (0.15%) |
occurrences causally related to treatment / all
|
0 / 10 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis acute
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis chronic
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis externa
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis media
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis media bacterial
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian abscess
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paronychia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer helicobacter
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonsillar abscess
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periumbilical abscess
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngitis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngitis streptococcal
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
subjects affected / exposed
|
37 / 5291 (0.70%) |
57 / 5286 (1.08%) |
occurrences causally related to treatment / all
|
0 / 40 |
0 / 62 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 4 |
Pneumonia adenoviral
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia bacterial
|
|
|
subjects affected / exposed
|
17 / 5291 (0.32%) |
39 / 5286 (0.74%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 42 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Pneumonia haemophilus
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia influenzal
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pneumonia klebsiella
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia pneumococcal
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia streptococcal
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia viral
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural pneumonia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
subjects affected / exposed
|
6 / 5291 (0.11%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psoas abscess
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary sepsis
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pulmonary tuberculosis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelitis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
10 / 5291 (0.19%) |
10 / 5286 (0.19%) |
occurrences causally related to treatment / all
|
2 / 10 |
3 / 10 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pyelonephritis acute
|
|
|
subjects affected / exposed
|
7 / 5291 (0.13%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
2 / 7 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pyelonephritis chronic
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Q fever
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal abscess
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scrotal abscess
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sepsis
|
|
|
subjects affected / exposed
|
13 / 5291 (0.25%) |
12 / 5286 (0.23%) |
occurrences causally related to treatment / all
|
2 / 13 |
1 / 12 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 4 |
Septic shock
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Sinusitis aspergillus
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin infection
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue infection
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal bacteraemia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal skin infection
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcal bacteraemia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous abscess
|
|
|
subjects affected / exposed
|
4 / 5291 (0.08%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdiaphragmatic abscess
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suspected COVID-19
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Systemic infection
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic viral infection
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheitis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheobronchitis
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper respiratory tract infection bacterial
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
8 / 5291 (0.15%) |
10 / 5286 (0.19%) |
occurrences causally related to treatment / all
|
3 / 8 |
5 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection bacterial
|
|
|
subjects affected / exposed
|
9 / 5291 (0.17%) |
13 / 5286 (0.25%) |
occurrences causally related to treatment / all
|
2 / 9 |
2 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection fungal
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
subjects affected / exposed
|
12 / 5291 (0.23%) |
10 / 5286 (0.19%) |
occurrences causally related to treatment / all
|
4 / 14 |
7 / 10 |
deaths causally related to treatment / all
|
0 / 1 |
1 / 1 |
Vestibular neuronitis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral infection
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral myocarditis
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral upper respiratory tract infection
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulval cellulitis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulvovaginal candidiasis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Dehydration
|
|
|
subjects affected / exposed
|
6 / 5291 (0.11%) |
7 / 5286 (0.13%) |
occurrences causally related to treatment / all
|
0 / 6 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
subjects affected / exposed
|
5 / 5291 (0.09%) |
9 / 5286 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus inadequate control
|
|
|
subjects affected / exposed
|
17 / 5291 (0.32%) |
25 / 5286 (0.47%) |
occurrences causally related to treatment / all
|
0 / 21 |
2 / 27 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
subjects affected / exposed
|
11 / 5291 (0.21%) |
4 / 5286 (0.08%) |
occurrences causally related to treatment / all
|
1 / 11 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Diabetic metabolic decompensation
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
6 / 5286 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrolyte imbalance
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gout
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
10 / 5291 (0.19%) |
23 / 5286 (0.44%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemic hyperosmolar nonketotic syndrome
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
3 / 5286 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
subjects affected / exposed
|
14 / 5291 (0.26%) |
11 / 5286 (0.21%) |
occurrences causally related to treatment / all
|
1 / 14 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperuricaemia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypervolaemia
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoalbuminaemia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
35 / 5291 (0.66%) |
31 / 5286 (0.59%) |
occurrences causally related to treatment / all
|
11 / 39 |
9 / 37 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
9 / 5286 (0.17%) |
occurrences causally related to treatment / all
|
1 / 3 |
2 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hypovolaemia
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Increased insulin requirement
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
0 / 5286 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lactic acidosis
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic acidosis
|
|
|
subjects affected / exposed
|
14 / 5291 (0.26%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
2 / 14 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic disorder
|
|
|
subjects affected / exposed
|
0 / 5291 (0.00%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic syndrome
|
|
|
subjects affected / exposed
|
2 / 5291 (0.04%) |
2 / 5286 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obesity
|
|
|
subjects affected / exposed
|
1 / 5291 (0.02%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
subjects affected / exposed
|
3 / 5291 (0.06%) |
1 / 5286 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |