Serious adverse events
|
Rivaroxaban 2.5 mg bid + ASA 100 mg od |
Rivaroxaban placebo bid + ASA 100 mg od |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
948 / 3256 (29.12%) |
927 / 3248 (28.54%) |
number of deaths (all causes)
|
327 |
304 |
number of deaths resulting from adverse events
|
76 |
79 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Acute myeloid leukaemia
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma gastric
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Adenocarcinoma of colon
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
B-cell lymphoma
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Basal cell carcinoma
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
7 / 3248 (0.22%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign laryngeal neoplasm
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of skin
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign ovarian tumour
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct cancer
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
subjects affected / exposed
|
4 / 3256 (0.12%) |
4 / 3248 (0.12%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer stage IV
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bladder neoplasm
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone cancer
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
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
|
2 / 3256 (0.06%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchial carcinoma
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Central nervous system lymphoma
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cervix carcinoma
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangiocarcinoma
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholesteatoma
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
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
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic myelomonocytic leukaemia
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Colon cancer
|
|
|
subjects affected / exposed
|
5 / 3256 (0.15%) |
4 / 3248 (0.12%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Endometrial cancer
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Follicular thyroid cancer
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder cancer
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric cancer
|
|
|
subjects affected / exposed
|
5 / 3256 (0.15%) |
4 / 3248 (0.12%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gastric cancer stage I
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric cancer stage II
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hodgkin's disease
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal cancer
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal neoplasm
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
subjects affected / exposed
|
4 / 3256 (0.12%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lung adenocarcinoma recurrent
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lung adenocarcinoma stage IV
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung carcinoma cell type unspecified recurrent
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lung carcinoma cell type unspecified stage IV
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung squamous cell carcinoma stage IV
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to liver
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Metastases to lung
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to lymph nodes
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to neck
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Myelodysplastic syndrome
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Neoplasm malignant
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Neoplasm skin
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal carcinoma
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Oesophageal carcinoma recurrent
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oropharyngeal cancer
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic carcinoma
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Papillary serous endometrial carcinoma
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural mesothelioma
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Prostate cancer stage III
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Rectal cancer
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Rectal cancer stage I
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal cancer stage IV
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Rectosigmoid cancer
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Renal cancer
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small cell lung cancer
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
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
|
1 / 3256 (0.03%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Squamous cell carcinoma of skin
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the oral cavity
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the tongue
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
T-cell lymphoma
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Transitional cell carcinoma
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal adenoma
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon adenoma
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung cancer metastatic
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
Salivary gland adenoma
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to peritoneum
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Adenocarcinoma pancreas
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Oesophageal cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Neuroendocrine carcinoma
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lung neoplasm malignant
|
|
|
subjects affected / exposed
|
8 / 3256 (0.25%) |
14 / 3248 (0.43%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 7 |
Metastases to central nervous system
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic carcinoma stage IV
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Non-small cell lung cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Prostate cancer
|
|
|
subjects affected / exposed
|
9 / 3256 (0.28%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain neoplasm
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thymoma malignant
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic neoplasm
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Colorectal cancer
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal neoplasm
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract neoplasm
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lip and/or oral cavity cancer
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal neoplasm
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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 stage IV
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-small cell lung cancer
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal neoplasm
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pancreatic neoplasm
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung neoplasm
|
|
|
subjects affected / exposed
|
4 / 3256 (0.12%) |
4 / 3248 (0.12%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Rectal neoplasm
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gingival cancer
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head and neck cancer
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inflammatory pseudotumour
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenolymphoma
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung squamous cell carcinoma metastatic
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatic cancer
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatocellular carcinoma
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ductal adenocarcinoma of pancreas
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Malignant genitourinary tract neoplasm
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant neoplasm papilla of Vater
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin squamous cell carcinoma recurrent
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Aortic aneurysm
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
4 / 3248 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic dissection
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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
|
6 / 3256 (0.18%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertension
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
5 / 3248 (0.15%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
subjects affected / exposed
|
5 / 3256 (0.15%) |
6 / 3248 (0.18%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotension
|
|
|
subjects affected / exposed
|
4 / 3256 (0.12%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemic shock
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intermittent claudication
|
|
|
subjects affected / exposed
|
43 / 3256 (1.32%) |
52 / 3248 (1.60%) |
occurrences causally related to treatment / all
|
0 / 51 |
0 / 58 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphoedema
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral coldness
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
subjects affected / exposed
|
34 / 3256 (1.04%) |
29 / 3248 (0.89%) |
occurrences causally related to treatment / all
|
0 / 44 |
1 / 46 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral vascular disorder
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
5 / 3248 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Poor peripheral circulation
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Renovascular hypertension
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Temporal arteritis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
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
|
1 / 3256 (0.03%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphocele
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dry gangrene
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian artery stenosis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphorrhoea
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iliac artery stenosis
|
|
|
subjects affected / exposed
|
4 / 3256 (0.12%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stenosis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery aneurysm
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery occlusion
|
|
|
subjects affected / exposed
|
7 / 3256 (0.21%) |
9 / 3248 (0.28%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive urgency
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous occlusion
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angiopathy
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extremity necrosis
|
|
|
subjects affected / exposed
|
12 / 3256 (0.37%) |
8 / 3248 (0.25%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Peripheral embolism
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
subjects affected / exposed
|
125 / 3256 (3.84%) |
130 / 3248 (4.00%) |
occurrences causally related to treatment / all
|
1 / 156 |
0 / 182 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial occlusive disease
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic limb pain
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphatic fistula
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
subjects affected / exposed
|
25 / 3256 (0.77%) |
14 / 3248 (0.43%) |
occurrences causally related to treatment / all
|
0 / 29 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral venous disease
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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
|
|
|
Bladder calculus removal
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blepharoplasty
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid endarterectomy
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot amputation
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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 / 3256 (0.00%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia repair
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitrectomy
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radical prostatectomy
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus management
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transurethral bladder resection
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral revascularisation
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain tumour operation
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystoprostatectomy
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery angioplasty
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Amputation
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder polypectomy
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neoplasm surgery
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb reconstructive surgery
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery bypass
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery stent insertion
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eventration repair
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
Asthenia
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest discomfort
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest pain
|
|
|
subjects affected / exposed
|
4 / 3256 (0.12%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Crepitations
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Death
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gait disturbance
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Granuloma
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hernia
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
7 / 3248 (0.22%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral swelling
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Puncture site haemorrhage
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic inflammatory response syndrome
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Organ failure
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Inflammation
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug intolerance
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
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
|
3 / 3256 (0.09%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent thrombosis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stent-graft endoleak
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent occlusion
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent stenosis
|
|
|
subjects affected / exposed
|
11 / 3256 (0.34%) |
8 / 3248 (0.25%) |
occurrences causally related to treatment / all
|
2 / 11 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Vascular device occlusion
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
Anaphylactic reaction
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypersensitivity
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Social circumstances
|
|
|
Disease risk factor
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Benign prostatic hyperplasia
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical polyp
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic prolapse
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spermatocele
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine prolapse
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulvar dysplasia
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic obstruction
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulval eczema
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Acute pulmonary oedema
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute respiratory distress syndrome
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute respiratory failure
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
5 / 3248 (0.15%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Aspiration
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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
|
1 / 3256 (0.03%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
16 / 3256 (0.49%) |
9 / 3248 (0.28%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cough
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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
|
4 / 3256 (0.12%) |
6 / 3248 (0.18%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Emphysema
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal polyps
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal septum deviation
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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
|
3 / 3256 (0.09%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
subjects affected / exposed
|
5 / 3256 (0.15%) |
6 / 3248 (0.18%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Pneumothorax
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax spontaneous
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary congestion
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary fibrosis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Pulmonary hypertension
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
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
|
1 / 3256 (0.03%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory distress
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Respiratory failure
|
|
|
subjects affected / exposed
|
5 / 3256 (0.15%) |
4 / 3248 (0.12%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
Sinus polyp
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vocal cord polyp
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal lesion
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary mass
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsillar cyst
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic respiratory disease
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Acute interstitial pneumonitis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Acute psychosis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
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
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcoholism
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
subjects affected / exposed
|
4 / 3256 (0.12%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
5 / 3248 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug abuse
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intentional self-injury
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Organic brain syndrome
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
4 / 3248 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol withdrawal syndrome
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient psychosis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product issues
|
|
|
Device breakage
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device dislocation
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device occlusion
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Patient-device incompatibility
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device battery issue
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Bile duct stone
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis acute
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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
|
7 / 3256 (0.21%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
12 / 3248 (0.37%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholestasis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cirrhosis alcoholic
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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
|
3 / 3256 (0.09%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hepatic failure
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic function abnormal
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic steatosis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatorenal syndrome
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct obstruction
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary dyskinesia
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Steatohepatitis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Primary biliary cholangitis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Blood creatinine increased
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood glucose increased
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood potassium increased
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure increased
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiovascular function test abnormal
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystoscopy
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immunoglobulins decreased
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carbohydrate antigen 19-9 increased
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac stress test abnormal
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular test
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol poisoning
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain herniation
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carbon monoxide poisoning
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Compression fracture
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Concussion
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Failure to anastomose
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
subjects affected / exposed
|
5 / 3256 (0.15%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Femoral neck fracture
|
|
|
subjects affected / exposed
|
4 / 3256 (0.12%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
subjects affected / exposed
|
10 / 3256 (0.31%) |
12 / 3248 (0.37%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Forearm fracture
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fractured sacrum
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head injury
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
subjects affected / exposed
|
5 / 3256 (0.15%) |
5 / 3248 (0.15%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Intentional overdose
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple injuries
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Open fracture
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Patella fracture
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Penetrating abdominal trauma
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Seroma
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skull fractured base
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
4 / 3248 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic ulcer
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
subjects affected / exposed
|
4 / 3256 (0.12%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft occlusion
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic fracture
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
4 / 3248 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Contusion
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anastomotic stenosis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft thrombosis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thermal burn
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound complication
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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 / 3256 (0.03%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery restenosis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post laminectomy syndrome
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Underdose
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular procedure complication
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Post procedural bile leak
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural discharge
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural complication
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Chemical burn of skin
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural complication
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin laceration
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb injury
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
4 / 3248 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest injury
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Traumatic intracranial haemorrhage
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural oedema
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft complication
|
|
|
subjects affected / exposed
|
5 / 3256 (0.15%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral hyperperfusion syndrome
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal anastomotic leak
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone contusion
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periprosthetic fracture
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral arterial reocclusion
|
|
|
subjects affected / exposed
|
4 / 3256 (0.12%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal column injury
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft thrombosis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pubis fracture
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery restenosis
|
|
|
subjects affected / exposed
|
16 / 3256 (0.49%) |
15 / 3248 (0.46%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
4 / 3248 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin scar contracture
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural intestinal perforation
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft stenosis
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft restenosis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular access site haematoma
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial bypass thrombosis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial bypass occlusion
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial bypass stenosis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foreign body in gastrointestinal tract
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
Congenital bladder neck obstruction
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocele
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phimosis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenomatous polyposis coli
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Acute myocardial infarction
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
subjects affected / exposed
|
10 / 3256 (0.31%) |
10 / 3248 (0.31%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve stenosis
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia supraventricular
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
19 / 3256 (0.58%) |
20 / 3248 (0.62%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
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
|
3 / 3256 (0.09%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block first degree
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block second degree
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure
|
|
|
subjects affected / exposed
|
14 / 3256 (0.43%) |
14 / 3248 (0.43%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Cardiac failure acute
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
6 / 3248 (0.18%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure chronic
|
|
|
subjects affected / exposed
|
6 / 3256 (0.18%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure congestive
|
|
|
subjects affected / exposed
|
10 / 3256 (0.31%) |
8 / 3248 (0.25%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiac tamponade
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Cardiogenic shock
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Coronary artery disease
|
|
|
subjects affected / exposed
|
15 / 3256 (0.46%) |
21 / 3248 (0.65%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Coronary artery occlusion
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
subjects affected / exposed
|
4 / 3256 (0.12%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cyanosis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive heart disease
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial ischaemia
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial haemorrhage
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
Pericarditis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Right ventricular failure
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus arrest
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
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
|
3 / 3256 (0.09%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular arrhythmia
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular fibrillation
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
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
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiopulmonary failure
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Congestive cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute left ventricular failure
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachyarrhythmia
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus node dysfunction
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
Carotid artery stenosis
|
|
|
subjects affected / exposed
|
22 / 3256 (0.68%) |
24 / 3248 (0.74%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral atrophy
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral infarction
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic neuropathy
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness
|
|
|
subjects affected / exposed
|
5 / 3256 (0.15%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness postural
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drop attacks
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Guillain-Barre syndrome
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocephalus
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracranial aneurysm
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental impairment
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelopathy
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve compression
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuralgia
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parkinsonism
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyneuropathy
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Presyncope
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sciatica
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
4 / 3248 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Somnolence
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal claudication
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
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 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
Syncope
|
|
|
subjects affected / exposed
|
9 / 3256 (0.28%) |
11 / 3248 (0.34%) |
occurrences causally related to treatment / all
|
1 / 9 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Tension headache
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonic convulsion
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery occlusion
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical radiculopathy
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar radiculopathy
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial paresis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic neuropathy
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Restless legs syndrome
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Putamen haemorrhage
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cranial nerve disorder
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
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
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Parkinson's disease
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery disease
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular encephalopathy
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudoradicular syndrome
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain injury
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Colloid brain cyst
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sacral radiculopathy
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
subjects affected / exposed
|
14 / 3256 (0.43%) |
10 / 3248 (0.31%) |
occurrences causally related to treatment / all
|
10 / 16 |
4 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iron deficiency anaemia
|
|
|
subjects affected / exposed
|
4 / 3256 (0.12%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
2 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Microcytic anaemia
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normochromic normocytic anaemia
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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 / 3256 (0.03%) |
0 / 3248 (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
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytosis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrogenic anaemia
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood loss anaemia
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
Deafness
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden hearing loss
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Cataract
|
|
|
subjects affected / exposed
|
8 / 3256 (0.25%) |
8 / 3248 (0.25%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract subcapsular
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic retinopathy
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eyelid ptosis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glaucoma
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iridocyclitis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular degeneration
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular oedema
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myopia
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous haemorrhage
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular hole
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Detachment of macular retinal pigment epithelium
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreoretinal traction syndrome
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular detachment
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Abdominal adhesions
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal mass
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain lower
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fissure
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal stenosis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ascites
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic gastritis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Constipation
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Crohn's disease
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Dental alveolar anomaly
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diaphragmatic hernia
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dry mouth
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gallstone ileus
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
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
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric polyps
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
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
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal necrosis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired gastric emptying
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
subjects affected / exposed
|
4 / 3256 (0.12%) |
4 / 3248 (0.12%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal angina
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal ischaemia
|
|
|
subjects affected / exposed
|
4 / 3256 (0.12%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Intestinal obstruction
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Intestinal perforation
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal ulcer
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nausea
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
subjects affected / exposed
|
4 / 3256 (0.12%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
4 / 3248 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis chronic
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
4 / 3248 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis necrotising
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer perforation
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periodontal disease
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal perforation
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth loss
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia, obstructive
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Volvulus
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vomiting
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic mass
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subileus
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mechanical ileus
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric antral vascular ectasia
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
subjects affected / exposed
|
10 / 3256 (0.31%) |
4 / 3248 (0.12%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedematous pancreatitis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcoholic pancreatitis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestinal obstruction
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterovesical fistula
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic duct stenosis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal incarcerated hernia
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive pancreatitis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Angioedema
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decubitus ulcer
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermal cyst
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis allergic
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage subcutaneous
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hidradenitis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pemphigoid
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pemphigus
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin exfoliation
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin lesion
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin necrosis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
subjects affected / exposed
|
10 / 3256 (0.31%) |
12 / 3248 (0.37%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urticaria
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ulcer
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic skin eruption
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
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
|
9 / 3256 (0.28%) |
9 / 3248 (0.28%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug reaction with eosinophilia and systemic symptoms
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic skin ulcer
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myxoid cyst
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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
|
|
|
Calculus bladder
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus urinary
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvi-ureteric obstruction
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery stenosis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal colic
|
|
|
subjects affected / exposed
|
4 / 3256 (0.12%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure
|
|
|
subjects affected / exposed
|
6 / 3256 (0.18%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ureteric fistula
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary incontinence
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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 / 3256 (0.03%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
subjects affected / exposed
|
5 / 3256 (0.15%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Urethral stenosis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute kidney injury
|
|
|
subjects affected / exposed
|
9 / 3256 (0.28%) |
17 / 3248 (0.52%) |
occurrences causally related to treatment / all
|
0 / 9 |
1 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
End stage renal disease
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ureterolithiasis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Goitre
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid mass
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Arthritis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
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
|
3 / 3256 (0.09%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone disorder
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone formation increased
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical spinal stenosis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Compartment syndrome
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture nonunion
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gouty arthritis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaw cyst
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metatarsalgia
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle disorder
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle spasms
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteitis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
subjects affected / exposed
|
14 / 3256 (0.43%) |
13 / 3248 (0.40%) |
occurrences causally related to treatment / all
|
2 / 18 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoporotic fracture
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
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
|
6 / 3256 (0.18%) |
14 / 3248 (0.43%) |
occurrences causally related to treatment / all
|
0 / 6 |
1 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pathological fracture
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polymyalgia rheumatica
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
4 / 3248 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
4 / 3248 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Synovial cyst
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon disorder
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudarthrosis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
6 / 3256 (0.18%) |
6 / 3248 (0.18%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondyloarthropathy
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral column mass
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acquired claw toe
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
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
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament disorder
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue disorder
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone loss
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue necrosis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal pain
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic scleroderma
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal stenosis
|
|
|
subjects affected / exposed
|
6 / 3256 (0.18%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Abscess
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute sinusitis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
subjects affected / exposed
|
4 / 3256 (0.12%) |
5 / 3248 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerotic gangrene
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blister infected
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchiolitis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carbuncle
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
subjects affected / exposed
|
19 / 3256 (0.58%) |
18 / 3248 (0.55%) |
occurrences causally related to treatment / all
|
0 / 19 |
1 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis gangrenous
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gangrene
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea infectious
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
subjects affected / exposed
|
4 / 3256 (0.12%) |
5 / 3248 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear infection
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eczema infected
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epididymitis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
10 / 3248 (0.31%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fournier's gangrene
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fungal cystitis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fungal skin infection
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gangrene
|
|
|
subjects affected / exposed
|
16 / 3256 (0.49%) |
20 / 3248 (0.62%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis salmonella
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected skin ulcer
|
|
|
subjects affected / exposed
|
6 / 3256 (0.18%) |
4 / 3248 (0.12%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Localised infection
|
|
|
subjects affected / exposed
|
19 / 3256 (0.58%) |
11 / 3248 (0.34%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphangitis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal candidiasis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ophthalmic herpes zoster
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orchitis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
subjects affected / exposed
|
11 / 3256 (0.34%) |
12 / 3248 (0.37%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis chronic
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis media
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perinephric abscess
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periodontitis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngitis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
subjects affected / exposed
|
40 / 3256 (1.23%) |
45 / 3248 (1.39%) |
occurrences causally related to treatment / all
|
0 / 49 |
0 / 50 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 4 |
Postoperative wound infection
|
|
|
subjects affected / exposed
|
27 / 3256 (0.83%) |
25 / 3248 (0.77%) |
occurrences causally related to treatment / all
|
0 / 28 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudomembranous colitis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary tuberculosis
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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
|
12 / 3256 (0.37%) |
13 / 3248 (0.40%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 4 |
Septic shock
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
5 / 3248 (0.15%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 4 |
Sinusitis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin infection
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous abscess
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsillitis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tuberculosis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
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
|
13 / 3256 (0.40%) |
11 / 3248 (0.34%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection
|
|
|
subjects affected / exposed
|
17 / 3256 (0.52%) |
15 / 3248 (0.46%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
5 / 3248 (0.15%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcal sepsis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Scrotal abscess
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin abscess
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
subjects affected / exposed
|
6 / 3256 (0.18%) |
5 / 3248 (0.15%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin infection
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lymph gland infection
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periumbilical abscess
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Burn infection
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma infection
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary sepsis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Perineal abscess
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal infection
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft infection
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric infection
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
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
|
3 / 3256 (0.09%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected lymphocele
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral discitis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot infection
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
6 / 3248 (0.18%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia bacterial
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis infective
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extradural abscess
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Soft tissue infection
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Respiratory tract infection
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis infective
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related infection
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis bacterial
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis bacterial
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
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
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Post procedural sepsis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Superinfection bacterial
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural infection
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone abscess
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumocystis jirovecii pneumonia
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected seroma
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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
|
1 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device site joint infection
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perineal cellulitis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular device infection
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complicated appendicitis
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine infection
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Dehydration
|
|
|
subjects affected / exposed
|
6 / 3256 (0.18%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
subjects affected / exposed
|
6 / 3256 (0.18%) |
8 / 3248 (0.25%) |
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
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
subjects affected / exposed
|
2 / 3256 (0.06%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
3 / 3248 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
6 / 3248 (0.18%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
5 / 3248 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ketoacidosis
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
0 / 3248 (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 / 3256 (0.03%) |
0 / 3248 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metabolic disorder
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decreased appetite
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemic hyperosmolar nonketotic syndrome
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypophagia
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Type 1 diabetes mellitus
|
|
|
subjects affected / exposed
|
0 / 3256 (0.00%) |
2 / 3248 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
subjects affected / exposed
|
3 / 3256 (0.09%) |
5 / 3248 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic metabolic decompensation
|
|
|
subjects affected / exposed
|
1 / 3256 (0.03%) |
1 / 3248 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |