Serious adverse events
|
Clopidogrel 75mg od |
Ticagrelor 90mg bd |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
1788 / 6932 (25.79%) |
1716 / 6910 (24.83%) |
number of deaths (all causes)
|
290 |
271 |
number of deaths resulting from adverse events
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Adenocarcinoma gastric
|
|
|
subjects affected / exposed
|
9 / 6932 (0.13%) |
8 / 6910 (0.12%) |
occurrences causally related to treatment / all
|
1 / 9 |
1 / 8 |
deaths causally related to treatment / all
|
1 / 4 |
0 / 3 |
Adenocarcinoma of colon
|
|
|
subjects affected / exposed
|
7 / 6932 (0.10%) |
8 / 6910 (0.12%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Adenocarcinoma of salivary gland
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Adenocarcinoma pancreas
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Adenoma benign
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal gland cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal neoplasm
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
B-cell lymphoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
B-cell lymphoma stage IV
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign bone neoplasm
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign laryngeal neoplasm
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign ovarian tumour
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign renal neoplasm
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign salivary gland neoplasm
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct cancer
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Bladder cancer
|
|
|
subjects affected / exposed
|
12 / 6932 (0.17%) |
6 / 6910 (0.09%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bladder cancer recurrent
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer stage IV
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Bladder neoplasm
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Bladder transitional cell carcinoma stage III
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone cancer
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Bone cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Bone neoplasm
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bowen's disease
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain neoplasm
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Brain neoplasm benign
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain neoplasm malignant
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Breast cancer
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
9 / 6910 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Breast cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer recurrent
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchial carcinoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bronchial neoplasm
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervix cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cervix carcinoma stage III
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholesteatoma
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondrosarcoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic lymphocytic leukaemia
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic myeloid leukaemia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Chronic myelomonocytic leukaemia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clear cell renal cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
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
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
subjects affected / exposed
|
7 / 6932 (0.10%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Colon cancer metastatic
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Colon cancer recurrent
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon neoplasm
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal cancer
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
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 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Diffuse large B-cell lymphoma
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
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 stage IV
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Disseminated large cell lymphoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ductal adenocarcinoma of pancreas
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ear neoplasm
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial cancer
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial cancer recurrent
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Fibrosarcoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder adenocarcinoma
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Gallbladder cancer
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric cancer
|
|
|
subjects affected / exposed
|
8 / 6932 (0.12%) |
8 / 6910 (0.12%) |
occurrences causally related to treatment / all
|
1 / 8 |
2 / 8 |
deaths causally related to treatment / all
|
1 / 4 |
0 / 2 |
Gastric neoplasm
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal carcinoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal neoplasm
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal stromal tumour
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal tract adenoma
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glioblastoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gliomatosis cerebri
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemangioma
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemangiopericytoma
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head and neck cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hepatic cancer
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
1 / 2 |
0 / 0 |
Hepatic cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hepatic neoplasm
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hepatocellular carcinoma
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hodgkin's disease
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Huerthle cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Insulinoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraductal papillary mucinous neoplasm
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraductal proliferative breast lesion
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraocular melanoma
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive breast carcinoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive ductal breast carcinoma
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large cell lung cancer
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Large intestine benign neoplasm
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal cancer
|
|
|
subjects affected / exposed
|
10 / 6932 (0.14%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
Laryngeal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lip and/or oral cavity cancer
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Lip squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
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 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
subjects affected / exposed
|
11 / 6932 (0.16%) |
11 / 6910 (0.16%) |
occurrences causally related to treatment / all
|
0 / 11 |
1 / 11 |
deaths causally related to treatment / all
|
0 / 5 |
1 / 3 |
Lung adenocarcinoma metastatic
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung adenocarcinoma stage II
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma stage III
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma stage IV
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung cancer metastatic
|
|
|
subjects affected / exposed
|
10 / 6932 (0.14%) |
8 / 6910 (0.12%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 7 |
Lung carcinoma cell type unspecified stage 0
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Lung carcinoma cell type unspecified stage IV
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Lung neoplasm
|
|
|
subjects affected / exposed
|
8 / 6932 (0.12%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 0 |
Lung neoplasm malignant
|
|
|
subjects affected / exposed
|
22 / 6932 (0.32%) |
27 / 6910 (0.39%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 27 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 13 |
Lung squamous cell carcinoma stage I
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung squamous cell carcinoma stage II
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Malignant melanoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Malignant middle ear neoplasm
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant neoplasm of eyelid
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant neoplasm of pleura
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Malignant neoplasm of unknown primary site
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Malignant neoplasm progression
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
Meningioma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningioma benign
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesothelioma
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastases to bone
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to central nervous system
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Metastases to liver
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to lung
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to lymph nodes
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic bronchial carcinoma
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastatic gastric cancer
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastatic malignant melanoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic neoplasm
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
Metastatic renal cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastatic squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
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 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Myeloproliferative neoplasm
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal sinus cancer
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm malignant
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Neuroendocrine carcinoma metastatic
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroendocrine tumour
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
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
|
|
|
subjects affected / exposed
|
6 / 6932 (0.09%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Non-small cell lung cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
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 IV
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Nonkeratinising carcinoma of nasopharynx
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ocular neoplasm
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
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
|
3 / 6932 (0.04%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Oesophageal cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Oesophageal carcinoma
|
|
|
subjects affected / exposed
|
5 / 6932 (0.07%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Oesophageal neoplasm
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Oral neoplasm
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oropharyngeal cancer
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oropharyngeal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ovarian adenoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic carcinoma
|
|
|
subjects affected / exposed
|
6 / 6932 (0.09%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 2 |
Pancreatic carcinoma metastatic
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Pancreatic neoplasm
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Papillary cystadenoma lymphomatosum
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papillary thyroid cancer
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraneoplastic syndrome
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parathyroid tumour benign
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial effusion malignant
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal cancer
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal neoplasm
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pituitary tumour benign
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Plasmacytoma
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
subjects affected / exposed
|
19 / 6932 (0.27%) |
15 / 6910 (0.22%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer stage III
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic adenoma
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal cancer
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Rectal cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Rectal neoplasm
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectosigmoid cancer
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectosigmoid cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Renal cancer
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
6 / 6910 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Renal cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Renal cell carcinoma
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal neoplasm
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland cancer
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin cancer
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small cell lung cancer
|
|
|
subjects affected / exposed
|
5 / 6932 (0.07%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Small cell lung cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Small intestine adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spindle cell sarcoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of lung
|
|
|
subjects affected / exposed
|
8 / 6932 (0.12%) |
12 / 6910 (0.17%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 5 |
Squamous cell carcinoma of pharynx
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the oral cavity
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the tongue
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
T-cell lymphoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Throat cancer
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tongue cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Tongue neoplasm malignant stage unspecified
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (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
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transitional cell cancer of the renal pelvis and ureter
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transitional cell cancer of the renal pelvis and ureter recurrent
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (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
|
7 / 6932 (0.10%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric cancer
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral cancer
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine cancer
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal cancer stage 0
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulval cancer
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Waldenstrom's macroglobulinaemia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangiocarcinoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Kaposi's sarcoma
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal cancer recurrent
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Accelerated hypertension
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aneurysm
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aneurysm ruptured
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Aortic aneurysm
|
|
|
subjects affected / exposed
|
12 / 6932 (0.17%) |
9 / 6910 (0.13%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic aneurysm rupture
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic dissection
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic stenosis
|
|
|
subjects affected / exposed
|
12 / 6932 (0.17%) |
7 / 6910 (0.10%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic thrombosis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aorto-duodenal fistula
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Behcet's syndrome
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brachiocephalic artery stenosis
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
11 / 6932 (0.16%) |
12 / 6910 (0.17%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extremity necrosis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral artery aneurysm
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma
|
|
|
subjects affected / exposed
|
8 / 6932 (0.12%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
5 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertension
|
|
|
subjects affected / exposed
|
30 / 6932 (0.43%) |
20 / 6910 (0.29%) |
occurrences causally related to treatment / all
|
1 / 32 |
1 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
subjects affected / exposed
|
9 / 6932 (0.13%) |
10 / 6910 (0.14%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotension
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemic shock
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
1 / 2 |
0 / 1 |
Iliac artery perforation
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intermittent claudication
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphatic fistula
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphocele
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
May-Thurner syndrome
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
subjects affected / exposed
|
5 / 6932 (0.07%) |
7 / 6910 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery aneurysm
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
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
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral embolism
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phlebitis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phlebitis superficial
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renovascular hypertension
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shock
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shock haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Subclavian artery occlusion
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian artery stenosis
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian steal syndrome
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Temporal arteritis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thromboangiitis obliterans
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis superficial
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicophlebitis
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose vein
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose vein ruptured
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vasculitis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vena cava thrombosis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous perforation
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis limb
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
Asthenia
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest discomfort
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest pain
|
|
|
subjects affected / exposed
|
7 / 6932 (0.10%) |
9 / 6910 (0.13%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complication associated with device
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complication of device removal
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cyst
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Death
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Drowning
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
2 / 2 |
0 / 0 |
Face oedema
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fatigue
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised oedema
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device site erosion
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
subjects affected / exposed
|
5 / 6932 (0.07%) |
6 / 6910 (0.09%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 6 |
Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
37 / 6932 (0.53%) |
37 / 6910 (0.54%) |
occurrences causally related to treatment / all
|
0 / 38 |
0 / 40 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Puncture site haemorrhage
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (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
|
2 / 6932 (0.03%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue inflammation
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Strangulated hernia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (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
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent occlusion
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent restenosis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent stenosis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (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 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vessel puncture site haematoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (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
|
|
|
Allergy to arthropod sting
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Allergy to chemicals
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaphylactic reaction
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
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 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug hypersensitivity
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypersensitivity
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Overlap syndrome
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (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
|
|
|
Acquired phimosis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign prostatic hyperplasia
|
|
|
subjects affected / exposed
|
13 / 6932 (0.19%) |
10 / 6910 (0.14%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast enlargement
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast hyperplasia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast mass
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical dysplasia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystocele
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial hyperplasia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epididymal cyst
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cyst
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peyronie's disease
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (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
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatomegaly
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Testicular atrophy
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scrotal cyst
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine pain
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine polyp
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine prolapse
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal prolapse
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulvovaginal pain
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Acute pulmonary oedema
|
|
|
subjects affected / exposed
|
6 / 6932 (0.09%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Acute respiratory failure
|
|
|
subjects affected / exposed
|
6 / 6932 (0.09%) |
17 / 6910 (0.25%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Alveolitis allergic
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asphyxia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Asthma
|
|
|
subjects affected / exposed
|
6 / 6932 (0.09%) |
8 / 6910 (0.12%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthma-chronic obstructive pulmonary disease overlap syndrome
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atelectasis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis chronic
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchopneumopathy
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchostenosis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
71 / 6932 (1.02%) |
87 / 6910 (1.26%) |
occurrences causally related to treatment / all
|
3 / 100 |
3 / 113 |
deaths causally related to treatment / all
|
0 / 3 |
1 / 4 |
Chronic respiratory failure
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cough
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
11 / 6910 (0.16%) |
occurrences causally related to treatment / all
|
1 / 5 |
9 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea at rest
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea exertional
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Emphysema
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
6 / 6910 (0.09%) |
occurrences causally related to treatment / all
|
1 / 3 |
4 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
6 / 6910 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
3 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemothorax
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal cyst
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal dysplasia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung cyst
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mediastinal cyst
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal polyps
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal septum deviation
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oropharyngeal spasm
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal stenosis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
7 / 6932 (0.10%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleurisy
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
subjects affected / exposed
|
6 / 6932 (0.09%) |
8 / 6910 (0.12%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
Pneumothorax
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
8 / 6910 (0.12%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax spontaneous
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary arterial hypertension
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary congestion
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
15 / 6932 (0.22%) |
18 / 6910 (0.26%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary granuloma
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary hilum mass
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary hypertension
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary mass
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulmonary oedema
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
6 / 6910 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory distress
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
2 / 6910 (0.03%) |
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
|
12 / 6932 (0.17%) |
12 / 6910 (0.17%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 3 |
Respiratory tract inflammation
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sleep apnoea syndrome
|
|
|
subjects affected / exposed
|
5 / 6932 (0.07%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vocal cord polyp
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Affective disorder
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (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 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol abuse
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol withdrawal syndrome
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcoholism
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety disorder due to a general medical condition
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiovascular somatic symptom disorder
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Delirium
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
8 / 6932 (0.12%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug abuse
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug dependence
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Major depression
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental disorder due to a general medical condition
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicidal ideation
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicide attempt
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product issues
|
|
|
Device dislocation
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device failure
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device leakage
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device malfunction
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device occlusion
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Blood creatine phosphokinase MB increased
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood glucose fluctuation
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood urea increased
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
C-reactive protein increased
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Computerised tomogram thorax abnormal
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ejection fraction decreased
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram ST segment depression
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoglobin decreased
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoglobin increased
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza A virus test positive
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver function test increased
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Platelet count decreased
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic specific antigen increased
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salmonella test positive
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stool analysis abnormal
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid function test abnormal
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
Abdominal wound dehiscence
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acetabulum fracture
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol poisoning
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia postoperative
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anastomotic haemorrhage
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anastomotic ulcer haemorrhage
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthropod sting
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Avulsion fracture
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Burns second degree
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery restenosis
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical vertebral fracture
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest injury
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Comminuted fracture
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Concussion
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Contusion
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
subjects affected / exposed
|
8 / 6932 (0.12%) |
8 / 6910 (0.12%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
subjects affected / exposed
|
11 / 6932 (0.16%) |
12 / 6910 (0.17%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
subjects affected / exposed
|
13 / 6932 (0.19%) |
11 / 6910 (0.16%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Forearm fracture
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foreign body in eye
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft haemorrhage
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gun shot wound
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Head injury
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Heat exhaustion
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heat illness
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
subjects affected / exposed
|
13 / 6932 (0.19%) |
12 / 6910 (0.17%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Humerus fracture
|
|
|
subjects affected / exposed
|
10 / 6932 (0.14%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypobarism
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incision site erythema
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (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
|
6 / 6932 (0.09%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intentional overdose
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laceration
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament rupture
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament sprain
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb injury
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
subjects affected / exposed
|
6 / 6932 (0.09%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbosacral plexus injury
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple fractures
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple injuries
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle rupture
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve injury
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Open globe injury
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periprosthetic fracture
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax traumatic
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (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 / 6932 (0.01%) |
0 / 6910 (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 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematuria
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
subjects affected / exposed
|
7 / 6932 (0.10%) |
14 / 6910 (0.20%) |
occurrences causally related to treatment / all
|
1 / 7 |
4 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative ileus
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural complication
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
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
|
11 / 6932 (0.16%) |
8 / 6910 (0.12%) |
occurrences causally related to treatment / all
|
2 / 12 |
2 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural hypotension
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural nausea
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural pneumothorax
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pubis fracture
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiation fibrosis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
subjects affected / exposed
|
7 / 6932 (0.10%) |
8 / 6910 (0.12%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Scapula fracture
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seroma
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin injury
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin wound
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skull fracture
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal cord injury
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Spinal fracture
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous haematoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (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
|
7 / 6932 (0.10%) |
9 / 6910 (0.13%) |
occurrences causally related to treatment / all
|
4 / 7 |
3 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Subdural haemorrhage
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thermal burn
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
subjects affected / exposed
|
5 / 6932 (0.07%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic fracture
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic intracranial haemorrhage
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft complication
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm
|
|
|
subjects affected / exposed
|
5 / 6932 (0.07%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
Arteriovenous malformation
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Corneal dystrophy
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocele
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertrophic cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
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 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Angina pectoris
|
|
|
subjects affected / exposed
|
18 / 6932 (0.26%) |
32 / 6910 (0.46%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 34 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
subjects affected / exposed
|
6 / 6932 (0.09%) |
10 / 6910 (0.14%) |
occurrences causally related to treatment / all
|
0 / 8 |
1 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve disease
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve incompetence
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve stenosis
|
|
|
subjects affected / exposed
|
8 / 6932 (0.12%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia supraventricular
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriospasm coronary
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (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
|
67 / 6932 (0.97%) |
69 / 6910 (1.00%) |
occurrences causally related to treatment / all
|
0 / 69 |
1 / 69 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
subjects affected / exposed
|
6 / 6932 (0.09%) |
11 / 6910 (0.16%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial tachycardia
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block complete
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
6 / 6910 (0.09%) |
occurrences causally related to treatment / all
|
1 / 4 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block first degree
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block second degree
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
2 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradyarrhythmia
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
9 / 6910 (0.13%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
8 / 6932 (0.12%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bundle branch block left
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure
|
|
|
subjects affected / exposed
|
23 / 6932 (0.33%) |
28 / 6910 (0.41%) |
occurrences causally related to treatment / all
|
1 / 29 |
1 / 30 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure acute
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure chronic
|
|
|
subjects affected / exposed
|
6 / 6932 (0.09%) |
6 / 6910 (0.09%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure congestive
|
|
|
subjects affected / exposed
|
88 / 6932 (1.27%) |
68 / 6910 (0.98%) |
occurrences causally related to treatment / all
|
2 / 108 |
1 / 81 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac tamponade
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac ventricular thrombosis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiogenic shock
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiomyopathy
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiopulmonary failure
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiovascular insufficiency
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic left ventricular failure
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congestive cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
8 / 6910 (0.12%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery dissection
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart valve stenosis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive heart disease
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic cardiomyopathy
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left ventricular dysfunction
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left ventricular failure
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
subjects affected / exposed
|
5 / 6932 (0.07%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial ischaemia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nodal arrhythmia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Palpitations
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
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
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus node dysfunction
|
|
|
subjects affected / exposed
|
5 / 6932 (0.07%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus tachycardia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular extrasystoles
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachyarrhythmia
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachycardia paroxysmal
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tricuspid valve incompetence
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular arrhythmia
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular extrasystoles
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular fibrillation
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular hypokinesia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular tachyarrhythmia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular tachycardia
|
|
|
subjects affected / exposed
|
5 / 6932 (0.07%) |
10 / 6910 (0.14%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
Altered state of consciousness
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Amyotrophic lateral sclerosis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (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
|
2 / 6932 (0.03%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal ganglia infarction
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain injury
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery aneurysm
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery disease
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery occlusion
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
subjects affected / exposed
|
60 / 6932 (0.87%) |
56 / 6910 (0.81%) |
occurrences causally related to treatment / all
|
0 / 64 |
1 / 58 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cauda equina syndrome
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar haemorrhage
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 2 |
Cerebral atrophy
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
2 / 3 |
2 / 2 |
deaths causally related to treatment / all
|
2 / 2 |
1 / 1 |
Cerebral infarction
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral ischaemia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cerebrovascular insufficiency
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical myelopathy
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervicobrachial syndrome
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cognitive disorder
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Coma
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cranial nerve disorder
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depressed level of consciousness
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic coma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic neuropathy
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness
|
|
|
subjects affected / exposed
|
6 / 6932 (0.09%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug withdrawal convulsions
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysaesthesia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolic stroke
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial paralysis
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised tonic-clonic seizure
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Guillain-Barre syndrome
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
subjects affected / exposed
|
6 / 6932 (0.09%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
2 / 6 |
1 / 4 |
deaths causally related to treatment / all
|
1 / 4 |
0 / 1 |
Haemorrhagic cerebral infarction
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (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
|
6 / 6932 (0.09%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
3 / 6 |
2 / 5 |
deaths causally related to treatment / all
|
2 / 4 |
1 / 1 |
Headache
|
|
|
subjects affected / exposed
|
6 / 6932 (0.09%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemianopia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiplegia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocephalus
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperaesthesia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic coma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic seizure
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxic-ischaemic encephalopathy
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
IIIrd nerve paralysis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Internal carotid artery kinking
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracranial aneurysm
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic cerebral infarction
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lacunar infarction
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar radiculopathy
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbosacral plexopathy
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Monoplegia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple sclerosis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple system atrophy
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myoclonus
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve compression
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve root compression
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorder
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuralgia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraesthesia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraparesis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parkinsonism
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Partial seizures
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyneuropathy
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post stroke epilepsy
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (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
|
5 / 6932 (0.07%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radial nerve compression
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radicular pain
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radicular syndrome
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiculopathy
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Restless legs syndrome
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ruptured cerebral aneurysm
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Sciatica
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seizure
|
|
|
subjects affected / exposed
|
7 / 6932 (0.10%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sleep paralysis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal cord compression
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylitic myelopathy
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Status epilepticus
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
subjects affected / exposed
|
7 / 6932 (0.10%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 7 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
2 / 3 |
Syncope
|
|
|
subjects affected / exposed
|
18 / 6932 (0.26%) |
26 / 6910 (0.38%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 27 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thalamus haemorrhage
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic encephalopathy
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient global amnesia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
subjects affected / exposed
|
6 / 6932 (0.09%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular dementia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebrobasilar insufficiency
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wernicke's encephalopathy
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
subjects affected / exposed
|
38 / 6932 (0.55%) |
39 / 6910 (0.56%) |
occurrences causally related to treatment / all
|
8 / 40 |
14 / 43 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia macrocytic
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia of chronic disease
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aplastic anaemia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Autoimmune aplastic anaemia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Febrile neutropenia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemolytic uraemic syndrome
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic anaemia
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypochromic anaemia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
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
|
4 / 6932 (0.06%) |
6 / 6910 (0.09%) |
occurrences causally related to treatment / all
|
1 / 4 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenitis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenopathy
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Microcytic anaemia
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
1 / 2 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normochromic normocytic anaemia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
Acute vestibular syndrome
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deafness
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoacusis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniere's disease
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Middle ear effusion
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (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
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tinnitus
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo
|
|
|
subjects affected / exposed
|
7 / 6932 (0.10%) |
9 / 6910 (0.13%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular disorder
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Angle closure glaucoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract
|
|
|
subjects affected / exposed
|
14 / 6932 (0.20%) |
14 / 6910 (0.20%) |
occurrences causally related to treatment / all
|
0 / 17 |
1 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Conjunctival haemorrhage
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic retinopathy
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Exophthalmos
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye haemorrhage
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
3 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular hole
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Open angle glaucoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Optic ischaemic neuropathy
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Optic neuropathy
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal artery embolism
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal degeneration
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
subjects affected / exposed
|
6 / 6932 (0.09%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal vein occlusion
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinoschisis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uveitis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vision blurred
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous haemorrhage
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Abdominal adhesions
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal discomfort
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal hernia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
subjects affected / exposed
|
9 / 6932 (0.13%) |
8 / 6910 (0.12%) |
occurrences causally related to treatment / all
|
0 / 9 |
1 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Abdominal pain upper
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
8 / 6910 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall haematoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acid peptic disease
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute abdomen
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcoholic pancreatitis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fistula
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal incontinence
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ascites
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Barrett's oesophagus
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic gastritis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
6 / 6910 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Constipation
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
1 / 3 |
3 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal polyp
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
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 / 6932 (0.01%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
1 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Duodenitis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epigastric discomfort
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erosive duodenitis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erosive oesophagitis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Food poisoning
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric disorder
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric haemorrhage
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
3 / 3 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric polyps
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
2 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
subjects affected / exposed
|
5 / 6932 (0.07%) |
6 / 6910 (0.09%) |
occurrences causally related to treatment / all
|
4 / 5 |
5 / 6 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Gastric ulcer perforation
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
10 / 6932 (0.14%) |
8 / 6910 (0.12%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gastritis alcoholic
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroduodenal ulcer
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (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
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal angiodysplasia haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorder
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
38 / 6932 (0.55%) |
34 / 6910 (0.49%) |
occurrences causally related to treatment / all
|
29 / 41 |
22 / 39 |
deaths causally related to treatment / all
|
2 / 2 |
0 / 0 |
Gastrointestinal inflammation
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal obstruction
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal pain
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal polyp haemorrhage
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
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 / 6932 (0.09%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Haemorrhagic erosive gastritis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoids thrombosed
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoaesthesia oral
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
10 / 6910 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ileus paralytic
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Impaired gastric emptying
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated inguinal hernia
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated umbilical hernia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
subjects affected / exposed
|
22 / 6932 (0.32%) |
20 / 6910 (0.29%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia strangulated
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal infarction
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Intestinal ischaemia
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Intestinal perforation
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal polyp
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intra-abdominal haematoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Irritable bowel syndrome
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestinal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Large intestine polyp
|
|
|
subjects affected / exposed
|
15 / 6932 (0.22%) |
14 / 6910 (0.20%) |
occurrences causally related to treatment / all
|
3 / 16 |
1 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
1 / 2 |
2 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mallory-Weiss syndrome
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mechanical ileus
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melaena
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric artery stenosis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric artery thrombosis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric panniculitis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric vein thrombosis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mouth haemorrhage
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nausea
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedematous pancreatitis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal achalasia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal fistula
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal spasm
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal ulcer
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
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
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis ulcerative
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic cyst
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic mass
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic pseudocyst
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (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
|
8 / 6932 (0.12%) |
8 / 6910 (0.12%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pancreatitis acute
|
|
|
subjects affected / exposed
|
9 / 6932 (0.13%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis chronic
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis relapsing
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer haemorrhage
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periodontal disease
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Proctitis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
subjects affected / exposed
|
6 / 6932 (0.09%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
3 / 7 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal polyp
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reflux gastritis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal haematoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal haemorrhage
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal perforation
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal stenosis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Strangulated umbilical hernia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subileus
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tongue dysplasia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
7 / 6932 (0.10%) |
9 / 6910 (0.13%) |
occurrences causally related to treatment / all
|
4 / 7 |
7 / 9 |
deaths causally related to treatment / all
|
1 / 2 |
1 / 1 |
Volvulus
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vomiting
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Alcoholic liver disease
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Autoimmune hepatitis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct obstruction
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct stenosis
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct stone
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary dyskinesia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangiolitis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis acute
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
subjects affected / exposed
|
8 / 6932 (0.12%) |
14 / 6910 (0.20%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cholecystitis acute
|
|
|
subjects affected / exposed
|
10 / 6932 (0.14%) |
11 / 6910 (0.16%) |
occurrences causally related to treatment / all
|
2 / 10 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis chronic
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
13 / 6932 (0.19%) |
14 / 6910 (0.20%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholestasis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cirrhosis alcoholic
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fatty liver alcoholic
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder perforation
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
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
|
2 / 6932 (0.03%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Hepatic cyst
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic haematoma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis acute
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis alcoholic
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaundice cholestatic
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver injury
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Actinic keratosis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angioedema
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decubitus ulcer
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermal cyst
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis allergic
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot
|
|
|
subjects affected / exposed
|
8 / 6932 (0.12%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug eruption
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eczema
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkeratosis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrobiosis lipoidica diabeticorum
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Panniculitis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pemphigoid
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash generalised
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin ulcer haemorrhage
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stasis dermatitis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subacute cutaneous lupus erythematosus
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Swelling face
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic epidermal necrolysis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
Acute kidney injury
|
|
|
subjects affected / exposed
|
32 / 6932 (0.46%) |
48 / 6910 (0.69%) |
occurrences causally related to treatment / all
|
0 / 32 |
2 / 52 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Acute prerenal failure
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Azotaemia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bladder prolapse
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus urinary
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
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
|
13 / 6932 (0.19%) |
20 / 6910 (0.29%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cystitis haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic nephropathy
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
End stage renal disease
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (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
|
10 / 6932 (0.14%) |
8 / 6910 (0.12%) |
occurrences causally related to treatment / all
|
5 / 11 |
4 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage urinary tract
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
6 / 6932 (0.09%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive nephropathy
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephritis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
5 / 6932 (0.07%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephropathy
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephropathy toxic
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrotic syndrome
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perinephritis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Proteinuria
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal aneurysm
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal arteriosclerosis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery stenosis
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal atrophy
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal colic
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure
|
|
|
subjects affected / exposed
|
19 / 6932 (0.27%) |
14 / 6910 (0.20%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 3 |
Renal impairment
|
|
|
subjects affected / exposed
|
7 / 6932 (0.10%) |
6 / 6910 (0.09%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal tubular necrosis
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (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
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tubulointerstitial nephritis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureterolithiasis
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral obstruction
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urge incontinence
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary incontinence
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urogenital haemorrhage
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Adrenal insufficiency
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Goitre
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperthyroidism
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypothyroidism
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inappropriate antidiuretic hormone secretion
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid cyst
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid mass
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroiditis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Arthralgia
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthrofibrosis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthropathy
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back pain
|
|
|
subjects affected / exposed
|
7 / 6932 (0.10%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical spinal stenosis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondritis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondrocalcinosis pyrophosphate
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Compartment syndrome
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Costochondritis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dupuytren's contracture
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Exostosis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facet joint syndrome
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot deformity
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gouty arthritis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemarthrosis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc degeneration
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc disorder
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
15 / 6932 (0.22%) |
12 / 6910 (0.17%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaw cyst
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
subjects affected / exposed
|
6 / 6932 (0.09%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle haemorrhage
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle spasms
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myalgia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neck pain
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathic arthropathy
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteitis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
subjects affected / exposed
|
41 / 6932 (0.59%) |
40 / 6910 (0.58%) |
occurrences causally related to treatment / all
|
0 / 45 |
0 / 41 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteochondrosis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteolysis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoporotic fracture
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pathological fracture
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periarthritis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polymyalgia rheumatica
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudarthrosis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psoriatic arthropathy
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rheumatic disorder
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rheumatoid arthritis
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
subjects affected / exposed
|
7 / 6932 (0.10%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scleroderma
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue haemorrhage
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal column stenosis
|
|
|
subjects affected / exposed
|
7 / 6932 (0.10%) |
7 / 6910 (0.10%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal instability
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal ligament ossification
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
subjects affected / exposed
|
5 / 6932 (0.07%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal pain
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
6 / 6910 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Synovial cyst
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Synovial disorder
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic sclerosis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral foraminal stenosis
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Trigger finger
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Abdominal abscess
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal infection
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall abscess
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess intestinal
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess jaw
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess of salivary gland
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute hepatitis B
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Anal abscess
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
subjects affected / exposed
|
9 / 6932 (0.13%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis perforated
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous graft site infection
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
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
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atypical mycobacterial pneumonia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Bacteraemia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial infection
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary tract infection
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone abscess
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
subjects affected / exposed
|
19 / 6932 (0.27%) |
23 / 6910 (0.33%) |
occurrences causally related to treatment / all
|
0 / 19 |
2 / 24 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Campylobacter gastroenteritis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carbuncle
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
subjects affected / exposed
|
26 / 6932 (0.38%) |
27 / 6910 (0.39%) |
occurrences causally related to treatment / all
|
0 / 28 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis infective
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis infective
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Chronic hepatitis C
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic sinusitis
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
subjects affected / exposed
|
8 / 6932 (0.12%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile infection
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colonic abscess
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Corynebacterium bacteraemia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (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
|
0 / 6932 (0.00%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related infection
|
|
|
subjects affected / exposed
|
6 / 6932 (0.09%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot infection
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gangrene
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea infectious
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
subjects affected / exposed
|
7 / 6932 (0.10%) |
6 / 6910 (0.09%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
1 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Echinococciasis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Emphysematous cholecystitis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Empyema
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalitis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis enterococcal
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epididymitis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
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 / 6932 (0.01%) |
0 / 6910 (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
|
4 / 6932 (0.06%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia bacteraemia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia infection
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder abscess
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder empyema
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gangrene
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
13 / 6932 (0.19%) |
12 / 6910 (0.17%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis salmonella
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft infection
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin abscess
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin infection
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma infection
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes virus infection
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impetigo
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implant site infection
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incision site infection
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
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
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected seroma
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected skin ulcer
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infectious colitis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective exacerbation of chronic obstructive airways disease
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza
|
|
|
subjects affected / exposed
|
6 / 6932 (0.09%) |
8 / 6910 (0.12%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral discitis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kidney infection
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Klebsiella sepsis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngitis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver abscess
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Localised infection
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung abscess
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung infection
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
7 / 6910 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphangitis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mediastinitis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device site infection
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis tuberculous
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle abscess
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mycobacterium avium complex infection
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasopharyngitis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Necrotising fasciitis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal candidiasis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ophthalmic herpes zoster
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orchitis
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oropharyngeal candidiasis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
subjects affected / exposed
|
9 / 6932 (0.13%) |
7 / 6910 (0.10%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis chronic
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paronychia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periodontitis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
subjects affected / exposed
|
6 / 6932 (0.09%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pneumocystis jirovecii pneumonia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
subjects affected / exposed
|
164 / 6932 (2.37%) |
137 / 6910 (1.98%) |
occurrences causally related to treatment / all
|
0 / 175 |
0 / 141 |
deaths causally related to treatment / all
|
0 / 28 |
0 / 15 |
Pneumonia bacterial
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
6 / 6910 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia influenzal
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
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
|
1 / 6932 (0.01%) |
0 / 6910 (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 / 6932 (0.00%) |
1 / 6910 (0.01%) |
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 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural infection
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Postoperative abscess
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
subjects affected / exposed
|
10 / 6932 (0.14%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary sepsis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary tuberculosis
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis chronic
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal abscess
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
subjects affected / exposed
|
5 / 6932 (0.07%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rotavirus infection
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salmonellosis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scrotal abscess
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sepsis
|
|
|
subjects affected / exposed
|
21 / 6932 (0.30%) |
21 / 6910 (0.30%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 5 |
Septic shock
|
|
|
subjects affected / exposed
|
13 / 6932 (0.19%) |
11 / 6910 (0.16%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 9 |
Sialoadenitis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue infection
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic abscess
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal infection
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcal bacteraemia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous abscess
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdiaphragmatic abscess
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tetanus
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Tracheostomy infection
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tuberculosis
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tuberculous pleurisy
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral stricture post infection
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
40 / 6932 (0.58%) |
32 / 6910 (0.46%) |
occurrences causally related to treatment / all
|
0 / 48 |
1 / 34 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Urinary tract infection bacterial
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection fungal
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
subjects affected / exposed
|
4 / 6932 (0.06%) |
13 / 6910 (0.19%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Varicella zoster virus infection
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular neuronitis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (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
|
2 / 6932 (0.03%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection bacterial
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Cachexia
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
4 / 6910 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
Dehydration
|
|
|
subjects affected / exposed
|
9 / 6932 (0.13%) |
10 / 6910 (0.14%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
subjects affected / exposed
|
10 / 6932 (0.14%) |
14 / 6910 (0.20%) |
occurrences causally related to treatment / all
|
1 / 12 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus inadequate control
|
|
|
subjects affected / exposed
|
18 / 6932 (0.26%) |
11 / 6910 (0.16%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
6 / 6910 (0.09%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Diabetic metabolic decompensation
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrolyte imbalance
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
3 / 6910 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Failure to thrive
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gout
|
|
|
subjects affected / exposed
|
5 / 6932 (0.07%) |
2 / 6910 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
9 / 6932 (0.13%) |
15 / 6910 (0.22%) |
occurrences causally related to treatment / all
|
1 / 10 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
subjects affected / exposed
|
3 / 6932 (0.04%) |
5 / 6910 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperosmolar hyperglycaemic state
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hyperuricaemia
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypervolaemia
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
12 / 6932 (0.17%) |
17 / 6910 (0.25%) |
occurrences causally related to treatment / all
|
1 / 14 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
5 / 6932 (0.07%) |
6 / 6910 (0.09%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
10 / 6932 (0.14%) |
6 / 6910 (0.09%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic acidosis
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metabolic disorder
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metabolic syndrome
|
|
|
subjects affected / exposed
|
2 / 6932 (0.03%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shock hypoglycaemic
|
|
|
subjects affected / exposed
|
1 / 6932 (0.01%) |
0 / 6910 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
subjects affected / exposed
|
0 / 6932 (0.00%) |
1 / 6910 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |