Serious adverse events
|
IDeg |
IGlar |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
1473 / 3818 (38.58%) |
1517 / 3819 (39.72%) |
number of deaths (all causes)
|
202 |
221 |
number of deaths resulting from adverse events
|
6 |
12 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Acute leukaemia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute lymphocytic leukaemia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Acute myeloid leukaemia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Adenocarcinoma gastric
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma pancreas
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal adenoma
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adult T-cell lymphoma/leukaemia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
B-cell lymphoma
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
B-cell lymphoma stage III
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of bladder
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of thyroid gland
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (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
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer recurrent
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer stage 0, with cancer in situ
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma recurrent
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma stage I
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone cancer
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bowen's disease
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain neoplasm
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Breast cancer
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
Breast cancer stage I
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer stage II
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer stage IV
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac valve fibroelastoma
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
Choroid melanoma
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic myeloid leukaemia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon adenoma
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Colon cancer metastatic
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Colon cancer stage III
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diffuse large B-cell lymphoma recurrent
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Endometrial adenocarcinoma
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibroma
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gastrointestinal cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gastrointestinal tract adenoma
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cancer
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Hepatic cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatic neoplasm
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatocellular carcinoma
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
1 / 3 |
Intraductal proliferative breast lesion
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive ductal breast carcinoma
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Leiomyoma
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukaemia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lipoma
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung adenocarcinoma metastatic
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Lung adenocarcinoma stage II
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung adenocarcinoma stage IV
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung neoplasm malignant
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lymphoma
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Malignant melanoma
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma in situ
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant peritoneal neoplasm
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Meningioma benign
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesothelioma malignant
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastases to bone
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastases to central nervous system
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastases to liver
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Metastases to lung
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastases to lymph nodes
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic neoplasm
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastatic renal cell carcinoma
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Metastatic squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mucinous endometrial carcinoma
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelodysplastic syndrome
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroendocrine carcinoma metastatic
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Non-small cell lung cancer
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-small cell lung cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Non-small cell lung cancer stage I
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal carcinoma
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ovarian cancer recurrent
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cancer stage IV
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pancreatic carcinoma
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Pancreatic carcinoma metastatic
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 2 |
0 / 0 |
Pancreatic carcinoma stage IV
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Papillary cystadenoma lymphomatosum
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papillary thyroid cancer
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Parathyroid tumour benign
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Penile squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phaeochromocytoma
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pituitary tumour benign
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
subjects affected / exposed
|
11 / 3818 (0.29%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Prostate cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer stage I
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer stage II
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Rectal adenoma
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal cancer
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland cancer
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small cell lung cancer
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Small cell lung cancer extensive stage
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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 metastatic
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Soft tissue sarcoma
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Squamous cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Squamous cell carcinoma of lung
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Squamous cell carcinoma of skin
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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 tongue
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Testicular seminoma (pure) stage I
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Testis cancer
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid cancer
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsil cancer
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transitional cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tumour of ampulla of Vater
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric cancer
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine cancer
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Accelerated hypertension
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
7 / 3819 (0.18%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Aneurysm
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angiopathy
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Aortic aneurysm
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic stenosis
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Arterial haemorrhage
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Blood pressure inadequately controlled
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
13 / 3818 (0.34%) |
10 / 3819 (0.26%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dry gangrene
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Embolism arterial
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism venous
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Essential hypertension
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (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
|
1 / 3818 (0.03%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hypertension
|
|
|
subjects affected / exposed
|
17 / 3818 (0.45%) |
23 / 3819 (0.60%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hypertensive crisis
|
|
|
subjects affected / exposed
|
8 / 3818 (0.21%) |
8 / 3819 (0.21%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotension
|
|
|
subjects affected / exposed
|
14 / 3818 (0.37%) |
14 / 3819 (0.37%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypovolaemic shock
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intermittent claudication
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
6 / 3819 (0.16%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic limb pain
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Leriche syndrome
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphocele
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant hypertension
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Microangiopathy
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive shock
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Orthostatic hypotension
|
|
|
subjects affected / exposed
|
6 / 3818 (0.16%) |
8 / 3819 (0.21%) |
occurrences causally related to treatment / all
|
0 / 6 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
subjects affected / exposed
|
13 / 3818 (0.34%) |
12 / 3819 (0.31%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery aneurysm
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery occlusion
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral embolism
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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
|
3 / 3818 (0.08%) |
7 / 3819 (0.18%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Peripheral vascular disorder
|
|
|
subjects affected / exposed
|
11 / 3818 (0.29%) |
14 / 3819 (0.37%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral venous disease
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phlebitis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reperfusion injury
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shock haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian steal syndrome
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Superior vena cava stenosis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Temporal arteritis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular insufficiency
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
Abdominal hernia repair
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal panniculectomy
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (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
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angioplasty
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic aneurysm repair
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic stent insertion
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve replacement
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula operation
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac ablation
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac pacemaker battery replacement
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac pacemaker insertion
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac pacemaker replacement
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract operation
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colectomy
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colostomy closure
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary arterial stent insertion
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery bypass
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal switch
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrectomy
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric bypass
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hernia repair
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip arthroplasty
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hysterectomy
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implantable defibrillator insertion
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implantable defibrillator replacement
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia repair
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc operation
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intra-ocular injection
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jejunostomy
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint arthroplasty
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (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
|
4 / 3818 (0.10%) |
7 / 3819 (0.18%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Knee operation
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leg amputation
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic surgery
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagectomy
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rotator cuff repair
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Roux loop conversion
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal decompression
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal fusion surgery
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal laminectomy
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroidectomy
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transurethral prostatectomy
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia repair
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
Asthenia
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac complication associated with device
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac death
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Catheter site haematoma
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest discomfort
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest pain
|
|
|
subjects affected / exposed
|
16 / 3818 (0.42%) |
21 / 3819 (0.55%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complication associated with device
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cyst
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Death
|
|
|
subjects affected / exposed
|
27 / 3818 (0.71%) |
21 / 3819 (0.55%) |
occurrences causally related to treatment / all
|
0 / 27 |
2 / 21 |
deaths causally related to treatment / all
|
0 / 27 |
2 / 21 |
Fatigue
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foreign body reaction
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised oedema
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Impaired healing
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Local swelling
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (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 haemorrhage
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
47 / 3818 (1.23%) |
54 / 3819 (1.41%) |
occurrences causally related to treatment / all
|
0 / 48 |
0 / 63 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema due to cardiac disease
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral swelling
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyp
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (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 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden cardiac death
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Sudden death
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
8 / 3819 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 8 |
Surgical failure
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic inflammatory response syndrome
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent restenosis
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent stenosis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent thrombosis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
Anaphylactic reaction
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaphylactic shock
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug hypersensitivity
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal transplant failure
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Social circumstances
|
|
|
Social stay hospitalisation
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Balanoposthitis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign prostatic hyperplasia
|
|
|
subjects affected / exposed
|
9 / 3818 (0.24%) |
7 / 3819 (0.18%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast enlargement
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical cyst
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical dysplasia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervix haemorrhage uterine
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystocele
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial hyperplasia
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cyst
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatomegaly
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectocele
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine mass
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (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
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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
|
|
|
Acquired diaphragmatic eventration
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute pulmonary oedema
|
|
|
subjects affected / exposed
|
6 / 3818 (0.16%) |
6 / 3819 (0.16%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Acute respiratory distress syndrome
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Acute respiratory failure
|
|
|
subjects affected / exposed
|
24 / 3818 (0.63%) |
31 / 3819 (0.81%) |
occurrences causally related to treatment / all
|
0 / 26 |
0 / 35 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 8 |
Asthma
|
|
|
subjects affected / exposed
|
6 / 3818 (0.16%) |
8 / 3819 (0.21%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthma-chronic obstructive pulmonary disease overlap syndrome
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atelectasis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bronchial hyperreactivity
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
42 / 3818 (1.10%) |
56 / 3819 (1.47%) |
occurrences causally related to treatment / all
|
0 / 54 |
0 / 70 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 5 |
Chronic respiratory failure
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cough
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
subjects affected / exposed
|
11 / 3818 (0.29%) |
17 / 3819 (0.45%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea exertional
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea paroxysmal nocturnal
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemothorax
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
8 / 3819 (0.21%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Idiopathic pulmonary fibrosis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (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 / 3818 (0.03%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Laryngeal stenosis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal polyps
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal septum deviation
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-cardiogenic pulmonary oedema
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive airways disorder
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal oedema
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pickwickian syndrome
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
6 / 3819 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pleurisy
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleuritic pain
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonitis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pneumothorax
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pneumothorax spontaneous
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary congestion
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
15 / 3818 (0.39%) |
10 / 3819 (0.26%) |
occurrences causally related to treatment / all
|
0 / 15 |
2 / 10 |
deaths causally related to treatment / all
|
0 / 5 |
1 / 1 |
Pulmonary fibrosis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulmonary hypertension
|
|
|
subjects affected / exposed
|
6 / 3818 (0.16%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Pulmonary mass
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
subjects affected / exposed
|
6 / 3818 (0.16%) |
9 / 3819 (0.24%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulmonary sarcoidosis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary veno-occlusive disease
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Respiratory distress
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
subjects affected / exposed
|
22 / 3818 (0.58%) |
18 / 3819 (0.47%) |
occurrences causally related to treatment / all
|
1 / 23 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 4 |
Respiratory tract inflammation
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sleep apnoea syndrome
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
7 / 3819 (0.18%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Upper respiratory tract inflammation
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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 stress disorder
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Affective disorder
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aggression
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Agitation
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol withdrawal syndrome
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bipolar disorder
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Confusional state
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delirium
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
5 / 3818 (0.13%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression suicidal
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hallucination, visual
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intentional self-injury
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Major depression
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
subjects affected / exposed
|
7 / 3818 (0.18%) |
8 / 3819 (0.21%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paranoia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Personality change due to a general medical condition
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post stroke depression
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post-traumatic stress disorder
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychotic disorder
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Schizoaffective disorder
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Schizoaffective disorder bipolar type
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Schizophrenia
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicidal ideation
|
|
|
subjects affected / exposed
|
5 / 3818 (0.13%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicide attempt
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product issues
|
|
|
Device dislocation
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device failure
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device fastener issue
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device inappropriate shock delivery
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device lead damage
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device loosening
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device malfunction
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lead dislodgement
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Acute hepatic failure
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Alcoholic liver disease
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct obstruction
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct stone
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary dyskinesia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
subjects affected / exposed
|
8 / 3818 (0.21%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
subjects affected / exposed
|
6 / 3818 (0.16%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 6 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis chronic
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
8 / 3818 (0.21%) |
8 / 3819 (0.21%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic hepatic failure
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Dilatation intrahepatic duct acquired
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cirrhosis
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Hepatic failure
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic lesion
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis chronic active
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatorenal failure
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ischaemic hepatitis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Jaundice
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaundice cholestatic
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver disorder
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Non-alcoholic steatohepatitis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Portal vein thrombosis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sphincter of Oddi dysfunction
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (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
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Arteriogram coronary
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biopsy lung
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatine phosphokinase increased
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood glucose decreased
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood magnesium decreased
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood potassium decreased
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood potassium increased
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure increased
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac monitoring
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheterisation cardiac
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coagulation time prolonged
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ejection fraction decreased
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram ST segment abnormal
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram ST segment elevation
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram ST-T change
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
International normalised ratio increased
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical observation
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Troponin increased
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Weight decreased
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (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
|
|
|
Accident at work
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Accidental overdose
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol poisoning
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia postoperative
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaesthetic complication
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaesthetic complication pulmonary
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anastomotic ulcer
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Animal bite
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brachial plexus injury
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Burns third degree
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac valve replacement complication
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical vertebral fracture
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clavicle fracture
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Concussion
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Contusion
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery restenosis
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary vascular graft occlusion
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Drug administration error
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extra dose administered
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye injury
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
subjects affected / exposed
|
54 / 3818 (1.41%) |
55 / 3819 (1.44%) |
occurrences causally related to treatment / all
|
3 / 57 |
0 / 59 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Femoral neck fracture
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (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 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal injury
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal stoma complication
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrostomy tube site complication
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hand fracture
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Humerus fracture
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ilium fracture
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated incisional hernia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incision site haemorrhage
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intentional overdose
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laceration
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament rupture
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb injury
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple fractures
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple injuries
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle strain
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Overdose
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax traumatic
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post concussion syndrome
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural complication
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
subjects affected / exposed
|
5 / 3818 (0.13%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Post procedural myocardial infarction
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative fever
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative ileus
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative respiratory failure
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative thoracic procedure complication
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound complication
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural haemorrhage
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural hypotension
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural intestinal perforation
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary contusion
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
subjects affected / exposed
|
20 / 3818 (0.52%) |
18 / 3819 (0.47%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 2 |
Seroma
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stab wound
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stoma site reaction
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress fracture
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
subjects affected / exposed
|
5 / 3818 (0.13%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Subdural haemorrhage
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thermal burn
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (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
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transfusion-related acute lung injury
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic haematoma
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric injury
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular procedure complication
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrong drug administered
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
Congenital ureterocele
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Factor V deficiency
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal arteriovenous malformation
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic arteriovenous malformation
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertrophic cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteogenesis imperfecta
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phimosis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Acute coronary syndrome
|
|
|
subjects affected / exposed
|
11 / 3818 (0.29%) |
8 / 3819 (0.21%) |
occurrences causally related to treatment / all
|
2 / 12 |
1 / 8 |
deaths causally related to treatment / all
|
1 / 1 |
1 / 1 |
Acute left ventricular failure
|
|
|
subjects affected / exposed
|
7 / 3818 (0.18%) |
6 / 3819 (0.16%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Acute myocardial infarction
|
|
|
subjects affected / exposed
|
98 / 3818 (2.57%) |
115 / 3819 (3.01%) |
occurrences causally related to treatment / all
|
4 / 111 |
6 / 123 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 14 |
Angina pectoris
|
|
|
subjects affected / exposed
|
36 / 3818 (0.94%) |
48 / 3819 (1.26%) |
occurrences causally related to treatment / all
|
0 / 37 |
2 / 53 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Angina unstable
|
|
|
subjects affected / exposed
|
87 / 3818 (2.28%) |
79 / 3819 (2.07%) |
occurrences causally related to treatment / all
|
8 / 94 |
3 / 93 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Aortic valve disease
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve stenosis
|
|
|
subjects affected / exposed
|
7 / 3818 (0.18%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Arteriosclerosis coronary artery
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
7 / 3819 (0.18%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 5 |
Arteriospasm coronary
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
47 / 3818 (1.23%) |
56 / 3819 (1.47%) |
occurrences causally related to treatment / all
|
0 / 55 |
0 / 75 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
Atrial flutter
|
|
|
subjects affected / exposed
|
11 / 3818 (0.29%) |
6 / 3819 (0.16%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial tachycardia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block complete
|
|
|
subjects affected / exposed
|
6 / 3818 (0.16%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block first degree
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block second degree
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular dissociation
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
8 / 3818 (0.21%) |
9 / 3819 (0.24%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bundle branch block left
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bundle branch block right
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiac arrest
|
|
|
subjects affected / exposed
|
26 / 3818 (0.68%) |
20 / 3819 (0.52%) |
occurrences causally related to treatment / all
|
0 / 26 |
3 / 21 |
deaths causally related to treatment / all
|
0 / 24 |
3 / 16 |
Cardiac discomfort
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorder
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiac failure
|
|
|
subjects affected / exposed
|
24 / 3818 (0.63%) |
30 / 3819 (0.79%) |
occurrences causally related to treatment / all
|
1 / 26 |
0 / 33 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 4 |
Cardiac failure acute
|
|
|
subjects affected / exposed
|
7 / 3818 (0.18%) |
8 / 3819 (0.21%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Cardiac failure chronic
|
|
|
subjects affected / exposed
|
8 / 3818 (0.21%) |
10 / 3819 (0.26%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiac failure congestive
|
|
|
subjects affected / exposed
|
134 / 3818 (3.51%) |
143 / 3819 (3.74%) |
occurrences causally related to treatment / all
|
2 / 177 |
5 / 206 |
deaths causally related to treatment / all
|
0 / 13 |
2 / 12 |
Cardiac hypertrophy
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac ventricular thrombosis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
subjects affected / exposed
|
12 / 3818 (0.31%) |
9 / 3819 (0.24%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 12 |
0 / 8 |
Cardiogenic shock
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Cardiomegaly
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiomyopathy
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
7 / 3819 (0.18%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Cardiopulmonary failure
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Cardiorenal syndrome
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiovascular disorder
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Chordae tendinae rupture
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic left ventricular failure
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congestive cardiomyopathy
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cor pulmonale
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cor pulmonale acute
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
subjects affected / exposed
|
80 / 3818 (2.10%) |
89 / 3819 (2.33%) |
occurrences causally related to treatment / all
|
4 / 85 |
1 / 91 |
deaths causally related to treatment / all
|
1 / 5 |
0 / 4 |
Coronary artery dissection
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery embolism
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery insufficiency
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery occlusion
|
|
|
subjects affected / exposed
|
12 / 3818 (0.31%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
subjects affected / exposed
|
12 / 3818 (0.31%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary ostial stenosis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diastolic dysfunction
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart valve incompetence
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive heart disease
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Intracardiac thrombus
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic cardiomyopathy
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
7 / 3819 (0.18%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Left ventricular dysfunction
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left ventricular failure
|
|
|
subjects affected / exposed
|
6 / 3818 (0.16%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left ventricular hypertrophy
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Long QT syndrome
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
subjects affected / exposed
|
48 / 3818 (1.26%) |
66 / 3819 (1.73%) |
occurrences causally related to treatment / all
|
0 / 51 |
3 / 68 |
deaths causally related to treatment / all
|
0 / 15 |
0 / 16 |
Myocardial ischaemia
|
|
|
subjects affected / exposed
|
7 / 3818 (0.18%) |
9 / 3819 (0.24%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Nodal arrhythmia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Palpitations
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prinzmetal angina
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulseless electrical activity
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Restrictive cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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
|
2 / 3818 (0.05%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Silent myocardial infarction
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus arrest
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus node dysfunction
|
|
|
subjects affected / exposed
|
6 / 3818 (0.16%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus tachycardia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systolic dysfunction
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachyarrhythmia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Tachycardia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tricuspid valve incompetence
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Trifascicular block
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular arrhythmia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular extrasystoles
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular fibrillation
|
|
|
subjects affected / exposed
|
6 / 3818 (0.16%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 1 |
Ventricular hypokinesia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular tachycardia
|
|
|
subjects affected / exposed
|
8 / 3818 (0.21%) |
12 / 3819 (0.31%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
Altered state of consciousness
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aphasia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ataxia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Balance disorder
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain injury
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Brain stem haemorrhage
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Brain stem infarction
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain stem stroke
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery disease
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery occlusion
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
subjects affected / exposed
|
15 / 3818 (0.39%) |
14 / 3819 (0.37%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar infarction
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cerebral arteriosclerosis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cerebral haemorrhage
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
Cerebral infarction
|
|
|
subjects affected / exposed
|
5 / 3818 (0.13%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cerebral ischaemia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral small vessel ischaemic disease
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
subjects affected / exposed
|
11 / 3818 (0.29%) |
22 / 3819 (0.58%) |
occurrences causally related to treatment / all
|
0 / 11 |
2 / 23 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 6 |
Cervical myelopathy
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cranial nerve paralysis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia Alzheimer's type
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Diabetic mononeuropathy
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic neuropathy
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness
|
|
|
subjects affected / exposed
|
7 / 3818 (0.18%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Dysarthria
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolic cerebral infarction
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolic stroke
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Encephalopathy
|
|
|
subjects affected / exposed
|
6 / 3818 (0.16%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Epidural lipomatosis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Essential tremor
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial paralysis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised tonic-clonic seizure
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Guillain-Barre syndrome
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
Haemorrhagic cerebral infarction
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Haemorrhagic stroke
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Haemorrhagic transformation stroke
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Headache
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
6 / 3819 (0.16%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiplegic migraine
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic encephalopathy
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocephalus
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hyperglycaemic seizure
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive encephalopathy
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoaesthesia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic coma
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic seizure
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
5 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic unconsciousness
|
|
|
subjects affected / exposed
|
27 / 3818 (0.71%) |
29 / 3819 (0.76%) |
occurrences causally related to treatment / all
|
19 / 29 |
23 / 33 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
Hypoxic-ischaemic encephalopathy
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
IIIrd nerve paralysis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intensive care unit acquired weakness
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Intracranial pressure increased
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ischaemic cerebral infarction
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
subjects affected / exposed
|
43 / 3818 (1.13%) |
45 / 3819 (1.18%) |
occurrences causally related to treatment / all
|
3 / 44 |
3 / 50 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Lacunar infarction
|
|
|
subjects affected / exposed
|
5 / 3818 (0.13%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lacunar stroke
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lethargy
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
1 / 4 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar radiculopathy
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Memory impairment
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
subjects affected / exposed
|
7 / 3818 (0.18%) |
9 / 3819 (0.24%) |
occurrences causally related to treatment / all
|
0 / 7 |
2 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Migraine
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Migraine-triggered seizure
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mononeuropathy multiplex
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Motor neurone disease
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple sclerosis relapse
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myasthenia gravis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve root compression
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normal pressure hydrocephalus
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraesthesia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parkinson's disease
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Peripheral sensory neuropathy
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post-injection delirium sedation syndrome
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Presyncope
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
12 / 3819 (0.31%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radicular pain
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiculopathy
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reversible ischaemic neurological deficit
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sciatica
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seizure
|
|
|
subjects affected / exposed
|
6 / 3818 (0.16%) |
6 / 3819 (0.16%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Senile dementia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal cord compression
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylitic myelopathy
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Status epilepticus
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (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
|
2 / 3818 (0.05%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Syncope
|
|
|
subjects affected / exposed
|
25 / 3818 (0.65%) |
24 / 3819 (0.63%) |
occurrences causally related to treatment / all
|
3 / 27 |
0 / 29 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thalamic infarction
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thalamus haemorrhage
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Thrombotic stroke
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic encephalopathy
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient global amnesia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
subjects affected / exposed
|
28 / 3818 (0.73%) |
42 / 3819 (1.10%) |
occurrences causally related to treatment / all
|
1 / 29 |
2 / 44 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tremor
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulnar nerve palsy
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VIth nerve paralysis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular dementia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Vascular headache
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebrobasilar insufficiency
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual field defect
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
subjects affected / exposed
|
11 / 3818 (0.29%) |
34 / 3819 (0.89%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 40 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Autoimmune haemolytic anaemia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coagulopathy
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coombs negative haemolytic anaemia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Evans syndrome
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemolytic anaemia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic anaemia
|
|
|
subjects affected / exposed
|
7 / 3818 (0.18%) |
9 / 3819 (0.24%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hypochromic anaemia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iron deficiency anaemia
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrogenic anaemia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normochromic normocytic anaemia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
Deafness neurosensory
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inner ear disorder
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniere's disease
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden hearing loss
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo
|
|
|
subjects affected / exposed
|
5 / 3818 (0.13%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular disorder
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Blindness
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract
|
|
|
subjects affected / exposed
|
9 / 3818 (0.24%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
1 / 13 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract diabetic
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (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
|
4 / 3818 (0.10%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glaucoma
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular fibrosis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurotrophic keratopathy
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Optic ischaemic neuropathy
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pterygium
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal artery occlusion
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal vein occlusion
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinopathy
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinopathy proliferative
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual impairment
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Abdominal discomfort
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal hernia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal hernia obstructive
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal mass
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
subjects affected / exposed
|
10 / 3818 (0.26%) |
10 / 3819 (0.26%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall haematoma
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acid peptic disease
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute abdomen
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Alcoholic pancreatitis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendix disorder
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Barrett's oesophagus
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic gastritis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
subjects affected / exposed
|
6 / 3818 (0.16%) |
6 / 3819 (0.16%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Constipation
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Crohn's disease
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gastroparesis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
subjects affected / exposed
|
11 / 3818 (0.29%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Diverticular perforation
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum
|
|
|
subjects affected / exposed
|
5 / 3818 (0.13%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal stenosis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal vascular ectasia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenitis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocele
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epigastric discomfort
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erosive duodenitis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric antral vascular ectasia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric perforation
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer perforation
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
8 / 3818 (0.21%) |
6 / 3819 (0.16%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroduodenitis haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal angiodysplasia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
10 / 3818 (0.26%) |
15 / 3819 (0.39%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Gastrointestinal polyp haemorrhage
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
subjects affected / exposed
|
6 / 3818 (0.16%) |
9 / 3819 (0.24%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematochezia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus paralytic
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired gastric emptying
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
7 / 3819 (0.18%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal ischaemia
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Intestinal obstruction
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Intra-abdominal haematoma
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Irritable bowel syndrome
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestinal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestinal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mallory-Weiss syndrome
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric haematoma
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nausea
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenic colitis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal rupture
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal varices haemorrhage
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic mass
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (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
|
7 / 3818 (0.18%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
subjects affected / exposed
|
6 / 3818 (0.16%) |
11 / 3819 (0.29%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis chronic
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer perforation
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periodontal disease
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumatosis intestinalis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland calculus
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland mass
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (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
|
9 / 3818 (0.24%) |
6 / 3819 (0.16%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spigelian hernia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
8 / 3819 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varices oesophageal
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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
|
5 / 3818 (0.13%) |
7 / 3819 (0.18%) |
occurrences causally related to treatment / all
|
1 / 5 |
1 / 7 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 1 |
Skin and subcutaneous tissue disorders
|
|
|
Angioedema
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
8 / 3819 (0.21%) |
occurrences causally related to treatment / all
|
2 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Decubitus ulcer
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Dermal cyst
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (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
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot
|
|
|
subjects affected / exposed
|
10 / 3818 (0.26%) |
11 / 3819 (0.29%) |
occurrences causally related to treatment / all
|
0 / 10 |
2 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic neuropathic ulcer
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eczema
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hidradenitis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperhidrosis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Hypersensitivity vasculitis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathic ulcer
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pemphigoid
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin necrosis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Skin ulcer
|
|
|
subjects affected / exposed
|
13 / 3818 (0.34%) |
6 / 3819 (0.16%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Skin ulcer haemorrhage
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stasis dermatitis
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urticaria
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
Acute kidney injury
|
|
|
subjects affected / exposed
|
70 / 3818 (1.83%) |
95 / 3819 (2.49%) |
occurrences causally related to treatment / all
|
0 / 79 |
2 / 110 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 6 |
Acute prerenal failure
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anuria
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Azotaemia
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Bladder neck obstruction
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder outlet obstruction
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus bladder
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus urinary
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
subjects affected / exposed
|
16 / 3818 (0.42%) |
26 / 3819 (0.68%) |
occurrences causally related to treatment / all
|
3 / 18 |
0 / 30 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 1 |
Cystitis noninfective
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic nephropathy
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
End stage renal disease
|
|
|
subjects affected / exposed
|
12 / 3818 (0.31%) |
9 / 3819 (0.24%) |
occurrences causally related to treatment / all
|
1 / 12 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
Glomerulonephritis rapidly progressive
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematuria
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
11 / 3818 (0.29%) |
9 / 3819 (0.24%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephropathy
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Nephropathy toxic
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrosclerosis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrotic syndrome
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery stenosis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure
|
|
|
subjects affected / exposed
|
14 / 3818 (0.37%) |
17 / 3819 (0.45%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Renal impairment
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal mass
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal tubular necrosis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stag horn calculus
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress urinary incontinence
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tubulointerstitial nephritis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureterolithiasis
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary hesitation
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (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
|
9 / 3818 (0.24%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Adrenal insufficiency
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Goitre
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypothyroidism
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid mass
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic goitre
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic nodular goitre
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Ankle deformity
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthralgia
|
|
|
subjects affected / exposed
|
5 / 3818 (0.13%) |
8 / 3819 (0.21%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
7 / 3819 (0.18%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthropathy
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back disorder
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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
|
7 / 3818 (0.18%) |
12 / 3819 (0.31%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical spinal stenosis
|
|
|
subjects affected / exposed
|
5 / 3818 (0.13%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondrocalcinosis pyrophosphate
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Costochondritis
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dactylitis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enthesopathy
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Exostosis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Flank pain
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot deformity
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gouty arthritis
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemarthrosis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Intervertebral disc degeneration
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc disorder
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
9 / 3818 (0.24%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint effusion
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
subjects affected / exposed
|
12 / 3818 (0.31%) |
7 / 3819 (0.18%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle spasms
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
6 / 3819 (0.16%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myopathy
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neck pain
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteitis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
subjects affected / exposed
|
32 / 3818 (0.84%) |
30 / 3819 (0.79%) |
occurrences causally related to treatment / all
|
0 / 35 |
0 / 31 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteopenia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoporosis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyarthritis
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polymyalgia rheumatica
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Rotator cuff syndrome
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue necrosis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal column stenosis
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylitis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Synovial cyst
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendonitis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral foraminal stenosis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Abdominal abscess
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal sepsis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Abdominal wall abscess
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall infection
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess rupture
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess soft tissue
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute endocarditis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
6 / 3819 (0.16%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerotic gangrene
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial infection
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial pyelonephritis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial sepsis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Beta haemolytic streptococcal infection
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
subjects affected / exposed
|
16 / 3818 (0.42%) |
21 / 3819 (0.55%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis bacterial
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis viral
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter site infection
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
subjects affected / exposed
|
52 / 3818 (1.36%) |
61 / 3819 (1.60%) |
occurrences causally related to treatment / all
|
1 / 64 |
1 / 72 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cellulitis orbital
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis staphylococcal
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis streptococcal
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest wall abscess
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis infective
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
subjects affected / exposed
|
8 / 3818 (0.21%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Clostridium difficile infection
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colonic abscess
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Conjunctivitis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dengue fever
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Dermatitis infected
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related infection
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot infection
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
8 / 3819 (0.21%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gangrene
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Disseminated cryptococcosis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (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
|
11 / 3818 (0.29%) |
14 / 3819 (0.37%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysentery
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eczema infected
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Empyema
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Endocarditis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epiglottitis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
External ear cellulitis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extradural abscess
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gangrene
|
|
|
subjects affected / exposed
|
5 / 3818 (0.13%) |
13 / 3819 (0.34%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gas gangrene
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
13 / 3818 (0.34%) |
12 / 3819 (0.31%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis Escherichia coli
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
7 / 3819 (0.18%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft infection
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin abscess
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
H1N1 influenza
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Helicobacter gastritis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incision site infection
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected bite
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected dermal cyst
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected seroma
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected skin ulcer
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infectious colitis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza
|
|
|
subjects affected / exposed
|
5 / 3818 (0.13%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Infusion site infection
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral discitis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint abscess
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Klebsiella sepsis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Labyrinthitis
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver abscess
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Localised infection
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lyme disease
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis aseptic
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis viral
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mucormycosis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrotising fasciitis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal candidiasis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oral candidiasis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orchitis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
subjects affected / exposed
|
20 / 3818 (0.52%) |
22 / 3819 (0.58%) |
occurrences causally related to treatment / all
|
0 / 26 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis acute
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis chronic
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis externa
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis media chronic
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraspinal abscess
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paronychia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perineal abscess
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perirectal abscess
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal abscess
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (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
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis bacterial
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngitis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pilonidal cyst
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
subjects affected / exposed
|
90 / 3818 (2.36%) |
90 / 3819 (2.36%) |
occurrences causally related to treatment / all
|
1 / 99 |
1 / 102 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 4 |
Pneumonia bacterial
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia influenzal
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia klebsiella
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia mycoplasmal
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia pneumococcal
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia pseudomonal
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia staphylococcal
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia streptococcal
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia viral
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural cellulitis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural infection
|
|
|
subjects affected / exposed
|
8 / 3818 (0.21%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural sepsis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative abscess
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
subjects affected / exposed
|
11 / 3818 (0.29%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate infection
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatitis Escherichia coli
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudomonal bacteraemia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary sepsis
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
11 / 3819 (0.29%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyuria
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal abscess
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal abscess
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory syncytial virus bronchitis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection viral
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salpingitis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (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
|
36 / 3818 (0.94%) |
31 / 3819 (0.81%) |
occurrences causally related to treatment / all
|
1 / 37 |
1 / 31 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 5 |
Sepsis pasteurella
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Sepsis syndrome
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Septic arthritis staphylococcal
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Septic embolus
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Septic shock
|
|
|
subjects affected / exposed
|
11 / 3818 (0.29%) |
12 / 3819 (0.31%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 5 |
Sialoadenitis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinusitis
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue infection
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal abscess
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal bacteraemia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal infection
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Staphylococcal sepsis
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Streptococcal bacteraemia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcal sepsis
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous abscess
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdiaphragmatic abscess
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth abscess
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheobronchitis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tuberculosis
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
subjects affected / exposed
|
5 / 3818 (0.13%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
34 / 3818 (0.89%) |
30 / 3819 (0.79%) |
occurrences causally related to treatment / all
|
0 / 37 |
0 / 37 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection bacterial
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
subjects affected / exposed
|
10 / 3818 (0.26%) |
9 / 3819 (0.24%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Viraemia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral infection
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
3 / 3819 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral pericarditis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulval abscess
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Decreased appetite
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dehydration
|
|
|
subjects affected / exposed
|
23 / 3818 (0.60%) |
16 / 3819 (0.42%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 3 |
Diabetes mellitus inadequate control
|
|
|
subjects affected / exposed
|
5 / 3818 (0.13%) |
4 / 3819 (0.10%) |
occurrences causally related to treatment / all
|
2 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Diabetic complication
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
subjects affected / exposed
|
5 / 3818 (0.13%) |
14 / 3819 (0.37%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Diabetic metabolic decompensation
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrolyte imbalance
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Failure to thrive
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fluid overload
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gout
|
|
|
subjects affected / exposed
|
4 / 3818 (0.10%) |
7 / 3819 (0.18%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperammonaemia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (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
|
11 / 3818 (0.29%) |
16 / 3819 (0.42%) |
occurrences causally related to treatment / all
|
1 / 12 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
subjects affected / exposed
|
18 / 3818 (0.47%) |
22 / 3819 (0.58%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hypernatraemia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
64 / 3818 (1.68%) |
49 / 3819 (1.28%) |
occurrences causally related to treatment / all
|
57 / 77 |
38 / 66 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
5 / 3819 (0.13%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypomagnesaemia
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
0 / 3819 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
8 / 3818 (0.21%) |
7 / 3819 (0.18%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hypovolaemia
|
|
|
subjects affected / exposed
|
2 / 3818 (0.05%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lactic acidosis
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
2 / 3819 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic acidosis
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Obesity
|
|
|
subjects affected / exposed
|
3 / 3818 (0.08%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudohyponatraemia
|
|
|
subjects affected / exposed
|
0 / 3818 (0.00%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
subjects affected / exposed
|
1 / 3818 (0.03%) |
1 / 3819 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |