Serious adverse events
|
Placebo |
Dapa 10 mg |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
3418 / 8569 (39.89%) |
3205 / 8574 (37.38%) |
number of deaths (all causes)
|
569 |
529 |
number of deaths resulting from adverse events
|
566 |
527 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Acral lentiginous melanoma
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute myeloid leukaemia
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Acute myelomonocytic leukaemia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma gastric
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Adenocarcinoma of appendix
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
subjects affected / exposed
|
18 / 8569 (0.21%) |
20 / 8574 (0.23%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Adenocarcinoma pancreas
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 5 |
1 / 1 |
Adenoid cystic carcinoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenoma benign
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal adenoma
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal neoplasm
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenocortical carcinoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaplastic astrocytoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Anaplastic large-cell lymphoma
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
B-cell lymphoma
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
subjects affected / exposed
|
27 / 8569 (0.32%) |
34 / 8574 (0.40%) |
occurrences causally related to treatment / all
|
0 / 37 |
0 / 42 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basosquamous carcinoma
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Benign breast neoplasm
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign ear neoplasm
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign gastric neoplasm
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign gastrointestinal neoplasm
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign hepatic neoplasm
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign laryngeal neoplasm
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign lung neoplasm
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign lymph node neoplasm
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of bladder
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of adrenal gland
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of thyroid gland
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of spinal cord
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign pancreatic neoplasm
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign renal neoplasm
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign salivary gland neoplasm
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign soft tissue neoplasm
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
subjects affected / exposed
|
25 / 8569 (0.29%) |
12 / 8574 (0.14%) |
occurrences causally related to treatment / all
|
3 / 25 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer recurrent
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer stage 0, with cancer in situ
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neoplasm
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder papilloma
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
subjects affected / exposed
|
8 / 8569 (0.09%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
2 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Bladder transitional cell carcinoma metastatic
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Bone cancer
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bone neoplasm
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bowen's disease
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain neoplasm
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Brain neoplasm benign
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain neoplasm malignant
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Breast cancer
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer female
|
|
|
subjects affected / exposed
|
20 / 8569 (0.23%) |
19 / 8574 (0.22%) |
occurrences causally related to treatment / all
|
0 / 22 |
2 / 20 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Breast cancer metastatic
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast neoplasm
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchial carcinoma
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cancer pain
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carcinoid tumour of the duodenum
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carcinoid tumour of the small bowel
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Central nervous system lymphoma
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cervix carcinoma
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangiocarcinoma
|
|
|
subjects affected / exposed
|
7 / 8569 (0.08%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 5 |
Chondromatosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondrosarcoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic leukaemia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic lymphocytic leukaemia
|
|
|
subjects affected / exposed
|
6 / 8569 (0.07%) |
7 / 8574 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic myeloid leukaemia
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clear cell renal cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Colon adenoma
|
|
|
subjects affected / exposed
|
7 / 8569 (0.08%) |
8 / 8574 (0.09%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
subjects affected / exposed
|
16 / 8569 (0.19%) |
16 / 8574 (0.19%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Colon cancer metastatic
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Colon neoplasm
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal cancer
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Colorectal cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Dermatofibrosarcoma protuberans
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial adenocarcinoma
|
|
|
subjects affected / exposed
|
7 / 8569 (0.08%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Endometrial cancer
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fallopian tube cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Follicular thyroid cancer
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibroadenoma of breast
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gallbladder adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder neoplasm
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gastric adenoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric cancer
|
|
|
subjects affected / exposed
|
8 / 8569 (0.09%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Gastric cancer stage 0
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal adenocarcinoma
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal carcinoma
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal stromal cancer
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal stromal tumour
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal tract adenoma
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gingival cancer
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Glioblastoma
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glioblastoma multiforme
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Glottis carcinoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemangioma
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemangiopericytoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hairy cell leukaemia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cancer
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 1 |
Hepatic cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatocellular carcinoma
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
8 / 8574 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 4 |
Hodgkin's disease
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hypopharyngeal cancer
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Infected neoplasm
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Intestinal adenocarcinoma
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraductal proliferative breast lesion
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive breast carcinoma
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive ductal breast carcinoma
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
9 / 8574 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive lobular breast carcinoma
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Juvenile melanoma benign
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Keratoacanthoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine benign neoplasm
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal cancer
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Laryngeal cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Laryngeal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lentigo maligna
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukaemia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Lipoma
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liposarcoma
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
subjects affected / exposed
|
6 / 8569 (0.07%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Lung cancer metastatic
|
|
|
subjects affected / exposed
|
14 / 8569 (0.16%) |
11 / 8574 (0.13%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 13 |
0 / 6 |
Lung carcinoma cell type unspecified stage 0
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung neoplasm
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Lung neoplasm malignant
|
|
|
subjects affected / exposed
|
21 / 8569 (0.25%) |
12 / 8574 (0.14%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 6 |
Lung squamous cell carcinoma metastatic
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Lymphocytic leukaemia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Malignant anorectal neoplasm
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
subjects affected / exposed
|
12 / 8569 (0.14%) |
13 / 8574 (0.15%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma in situ
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
6 / 8574 (0.07%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant neoplasm of pleura metastatic
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Malignant neoplasm of renal pelvis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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 unknown primary site
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Malignant peritoneal neoplasm
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Malignant pleural effusion
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melanocytic naevus
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melanoma recurrent
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningioma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningioma benign
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesothelioma malignant
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastases to adrenals
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to bone
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to central nervous system
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to lymph nodes
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to lung
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to peritoneum
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to rectum
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to spinal cord
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to spine
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic bronchial carcinoma
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastatic carcinoma of the bladder
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic gastric cancer
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Metastatic neoplasm
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastatic malignant melanoma
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Metastatic renal cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastatic squamous cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Monoclonal gammopathy
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelodysplastic syndrome
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Myeloproliferative neoplasm
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Nasopharyngeal cancer
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm malignant
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Neoplasm
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm prostate
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm skin
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroendocrine tumour of the lung
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Non-small cell lung cancer
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroendocrine tumour of the lung metastatic
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-small cell lung cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ocular neoplasm
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-small cell lung cancer recurrent
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Oesophageal adenocarcinoma
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Oesophageal carcinoma
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Oesophageal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oral neoplasm benign
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian adenoma
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cancer
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ovarian neoplasm
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian epithelial cancer
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pancreatic carcinoma
|
|
|
subjects affected / exposed
|
8 / 8569 (0.09%) |
9 / 8574 (0.10%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 5 |
Pancreatic carcinoma metastatic
|
|
|
subjects affected / exposed
|
9 / 8569 (0.11%) |
8 / 8574 (0.09%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 7 |
Pancreatic neoplasm
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Pancreatic neuroendocrine tumour
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatoblastoma
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papillary cystadenoma lymphomatosum
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papillary renal cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papillary serous endometrial carcinoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papillary thyroid cancer
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papillary tumour of renal pelvis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Parathyroid tumour benign
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic neoplasm
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Penile squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal carcinoma metastatic
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phaeochromocytoma
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal cancer
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pituitary tumour
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasma cell leukaemia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Plasma cell myeloma
|
|
|
subjects affected / exposed
|
6 / 8569 (0.07%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pleomorphic adenoma
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
subjects affected / exposed
|
55 / 8569 (0.64%) |
69 / 8574 (0.80%) |
occurrences causally related to treatment / all
|
0 / 55 |
3 / 70 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Prostate cancer metastatic
|
|
|
subjects affected / exposed
|
7 / 8569 (0.08%) |
6 / 8574 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Prostate cancer recurrent
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic adenoma
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal adenoma
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal cancer
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Rectal cancer metastatic
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Renal cancer
|
|
|
subjects affected / exposed
|
7 / 8569 (0.08%) |
10 / 8574 (0.12%) |
occurrences causally related to treatment / all
|
0 / 8 |
1 / 10 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Renal cell carcinoma
|
|
|
subjects affected / exposed
|
8 / 8569 (0.09%) |
10 / 8574 (0.12%) |
occurrences causally related to treatment / all
|
0 / 8 |
1 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal neoplasm
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
6 / 8574 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Retro-orbital neoplasm
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland cancer
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Salivary gland neoplasm
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sebaceous carcinoma
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seborrhoeic keratosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Signet-ring cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small cell lung cancer
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Small cell lung cancer extensive stage
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Small cell lung cancer metastatic
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Soft tissue sarcoma
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestine adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Spinal cord neoplasm
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
subjects affected / exposed
|
10 / 8569 (0.12%) |
8 / 8574 (0.09%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of lung
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Squamous cell carcinoma of skin
|
|
|
subjects affected / exposed
|
9 / 8569 (0.11%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the oral cavity
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
T-cell lymphoma
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the tongue
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Throat cancer
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid adenoma
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid cancer
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid neoplasm
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tongue neoplasm malignant stage unspecified
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
12 / 8569 (0.14%) |
11 / 8574 (0.13%) |
occurrences causally related to treatment / all
|
5 / 14 |
3 / 11 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Tonsil cancer
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transitional cell cancer of the renal pelvis and ureter
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transitional cell carcinoma recurrent
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tumour obstruction
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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 metastatic
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Uterine cancer
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal cancer stage 0
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulval cancer
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Vocal cord neoplasm
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulval cancer stage 0
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer stage II
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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 I
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Endometrial cancer stage I
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric cancer stage III
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (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 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung carcinoma cell type unspecified stage IV
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Malignant neoplasm of ampulla of Vater
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma stage IV
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-small cell lung cancer stage IV
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Prostate cancer stage IV
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Accelerated hypertension
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic aneurysm
|
|
|
subjects affected / exposed
|
10 / 8569 (0.12%) |
12 / 8574 (0.14%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Aortic aneurysm rupture
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angiopathy
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic stenosis
|
|
|
subjects affected / exposed
|
17 / 8569 (0.20%) |
22 / 8574 (0.26%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic dilatation
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic dissection
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial occlusive disease
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial insufficiency
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial disorder
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial thrombosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial perforation
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Arteritis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bleeding varicose vein
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure fluctuation
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Claudication of jaw muscles
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
12 / 8569 (0.14%) |
17 / 8574 (0.20%) |
occurrences causally related to treatment / all
|
0 / 12 |
2 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dry gangrene
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic vascular disorder
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Essential hypertension
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extremity necrosis
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
7 / 8574 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral artery aneurysm
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral artery embolism
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma
|
|
|
subjects affected / exposed
|
6 / 8569 (0.07%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic vasculitis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
27 / 8569 (0.32%) |
27 / 8574 (0.31%) |
occurrences causally related to treatment / all
|
0 / 31 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hypertensive crisis
|
|
|
subjects affected / exposed
|
24 / 8569 (0.28%) |
14 / 8574 (0.16%) |
occurrences causally related to treatment / all
|
0 / 28 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
subjects affected / exposed
|
7 / 8569 (0.08%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotension
|
|
|
subjects affected / exposed
|
14 / 8569 (0.16%) |
28 / 8574 (0.33%) |
occurrences causally related to treatment / all
|
1 / 14 |
2 / 29 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypovolaemic shock
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Iliac artery disease
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iliac artery embolism
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iliac artery occlusion
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intermittent claudication
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Internal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ischaemic limb pain
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jugular vein thrombosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leriche syndrome
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphatic fistula
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphoedema
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant hypertension
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Microangiopathy
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
subjects affected / exposed
|
12 / 8569 (0.14%) |
6 / 8574 (0.07%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
subjects affected / exposed
|
49 / 8569 (0.57%) |
43 / 8574 (0.50%) |
occurrences causally related to treatment / all
|
0 / 53 |
0 / 56 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Peripheral artery aneurysm
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery dissection
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery haematoma
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery occlusion
|
|
|
subjects affected / exposed
|
15 / 8569 (0.18%) |
14 / 8574 (0.16%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
subjects affected / exposed
|
20 / 8569 (0.23%) |
23 / 8574 (0.27%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 36 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral embolism
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral vascular disorder
|
|
|
subjects affected / exposed
|
19 / 8569 (0.22%) |
34 / 8574 (0.40%) |
occurrences causally related to treatment / all
|
0 / 21 |
1 / 46 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
subjects affected / exposed
|
35 / 8569 (0.41%) |
30 / 8574 (0.35%) |
occurrences causally related to treatment / all
|
0 / 41 |
0 / 32 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral venous disease
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phlebitis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Raynaud's phenomenon
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Shock haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Subclavian artery occlusion
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian steal syndrome
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian artery stenosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Superior vena cava stenosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Temporal arteritis
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thromboangiitis obliterans
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis superficial
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose ulceration
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose vein
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular occlusion
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vasculitis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vasospasm
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
Hospitalisation
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
Adverse drug reaction
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthenia
|
|
|
subjects affected / exposed
|
10 / 8569 (0.12%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest pain
|
|
|
subjects affected / exposed
|
20 / 8569 (0.23%) |
29 / 8574 (0.34%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 34 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac death
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Complication associated with device
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Critical illness
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Death
|
|
|
subjects affected / exposed
|
89 / 8569 (1.04%) |
81 / 8574 (0.94%) |
occurrences causally related to treatment / all
|
0 / 89 |
0 / 81 |
deaths causally related to treatment / all
|
0 / 89 |
0 / 81 |
Dehiscence
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drowning
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Drug intolerance
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Exercise tolerance decreased
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug withdrawal syndrome
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Generalised oedema
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hernia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Granuloma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypothermia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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 / 8569 (0.04%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implant site inflammation
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated hernia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inflammation
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device pain
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malaise
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device site irritation
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Microlithiasis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
subjects affected / exposed
|
8 / 8569 (0.09%) |
9 / 8574 (0.10%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 4 |
Necrobiosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
107 / 8569 (1.25%) |
93 / 8574 (1.08%) |
occurrences causally related to treatment / all
|
1 / 120 |
0 / 110 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Organ failure
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pacemaker syndrome
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic mass
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral swelling
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
subjects affected / exposed
|
13 / 8569 (0.15%) |
7 / 8574 (0.08%) |
occurrences causally related to treatment / all
|
0 / 13 |
1 / 14 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Soft tissue inflammation
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stent-graft endoleak
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Submandibular mass
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden cardiac death
|
|
|
subjects affected / exposed
|
16 / 8569 (0.19%) |
14 / 8574 (0.16%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 16 |
0 / 14 |
Sudden death
|
|
|
subjects affected / exposed
|
23 / 8569 (0.27%) |
21 / 8574 (0.24%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 23 |
0 / 21 |
Systemic inflammatory response syndrome
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent occlusion
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
8 / 8569 (0.09%) |
7 / 8574 (0.08%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent thrombosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
Allergy to metals
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Allergy to vaccine
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaphylactic reaction
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaphylactic shock
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Drug hypersensitivity
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hashitoxicosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypersensitivity
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sarcoidosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Acquired hydrocele
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acquired phimosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
11 / 8574 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Balanoposthitis
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign prostatic hyperplasia
|
|
|
subjects affected / exposed
|
31 / 8569 (0.36%) |
28 / 8574 (0.33%) |
occurrences causally related to treatment / all
|
0 / 31 |
0 / 30 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast mass
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast pain
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical dysplasia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colpocele
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial hyperplasia
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial hypertrophy
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erectile dysfunction
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Female genital tract fistula
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gynaecomastia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrosalpinx
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic prolapse
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Penile necrosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peyronie's disease
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postmenopausal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic disorder
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
8 / 8569 (0.09%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
2 / 9 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatomegaly
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectocele
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Testicular cyst
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine polyp
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine prolapse
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
6 / 8574 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterovaginal prolapse
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal dysplasia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal prolapse
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicocele
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
8 / 8569 (0.09%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Acute respiratory distress syndrome
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Acute respiratory failure
|
|
|
subjects affected / exposed
|
43 / 8569 (0.50%) |
37 / 8574 (0.43%) |
occurrences causally related to treatment / all
|
0 / 50 |
0 / 41 |
deaths causally related to treatment / all
|
0 / 12 |
0 / 5 |
Alveolitis allergic
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Apnoea
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aspiration
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthma
|
|
|
subjects affected / exposed
|
18 / 8569 (0.21%) |
6 / 8574 (0.07%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthma-chronic obstructive pulmonary disease overlap syndrome
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthmatic crisis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atelectasis
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchial hyperreactivity
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
54 / 8569 (0.63%) |
54 / 8574 (0.63%) |
occurrences causally related to treatment / all
|
0 / 90 |
1 / 81 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 5 |
Chronic respiratory failure
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Dyspnoea
|
|
|
subjects affected / exposed
|
21 / 8569 (0.25%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Dyspnoea exertional
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Emphysema
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Haemothorax
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrothorax
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Hypoxia
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Idiopathic pulmonary fibrosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung infiltration
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal polyps
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraneoplastic pleural effusion
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Obstructive airways disorder
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal septum deviation
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pickwickian syndrome
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
13 / 8569 (0.15%) |
6 / 8574 (0.07%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pleural thickening
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleurisy
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleuritic pain
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
subjects affected / exposed
|
10 / 8569 (0.12%) |
18 / 8574 (0.21%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Pulmonary amyloidosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonitis
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
6 / 8574 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary arterial hypertension
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary congestion
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
27 / 8569 (0.32%) |
26 / 8574 (0.30%) |
occurrences causally related to treatment / all
|
0 / 27 |
1 / 26 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 5 |
Pulmonary hypertension
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary haemorrhage
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulmonary fibrosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary infarction
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pulmonary mass
|
|
|
subjects affected / exposed
|
11 / 8569 (0.13%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reflux laryngitis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
subjects affected / exposed
|
15 / 8569 (0.18%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
2 / 16 |
0 / 4 |
deaths causally related to treatment / all
|
1 / 4 |
0 / 0 |
Pulmonary thrombosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Respiratory acidosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory arrest
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Respiratory distress
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
subjects affected / exposed
|
24 / 8569 (0.28%) |
29 / 8574 (0.34%) |
occurrences causally related to treatment / all
|
0 / 28 |
1 / 30 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 7 |
Restrictive pulmonary disease
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rheumatoid lung
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhinitis hypertrophic
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vocal cord leukoplakia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Acute psychosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adjustment disorder
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol withdrawal syndrome
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety disorder
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Confusional state
|
|
|
subjects affected / exposed
|
12 / 8569 (0.14%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
2 / 12 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Conversion disorder
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delirium
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depressed mood
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
13 / 8569 (0.15%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug abuse
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hallucination
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypomania
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
6 / 8569 (0.07%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
subjects affected / exposed
|
7 / 8569 (0.08%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Mood disorder due to a general medical condition
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Panic attack
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post-traumatic stress disorder
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Restlessness
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Schizoaffective disorder
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Schizophrenia
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Schizoaffective disorder depressive type
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sleep disorder
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicidal ideation
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicide attempt
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product issues
|
|
|
Device breakage
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device dislocation
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device failure
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device lead damage
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device malfunction
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device occlusion
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stent malfunction
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Bile duct obstruction
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct stenosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct stone
|
|
|
subjects affected / exposed
|
8 / 8569 (0.09%) |
9 / 8574 (0.10%) |
occurrences causally related to treatment / all
|
0 / 8 |
1 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary colic
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary dyskinesia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary dyspepsia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
11 / 8574 (0.13%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis acute
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cholecystitis
|
|
|
subjects affected / exposed
|
22 / 8569 (0.26%) |
18 / 8574 (0.21%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
subjects affected / exposed
|
22 / 8569 (0.26%) |
25 / 8574 (0.29%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cholecystitis chronic
|
|
|
subjects affected / exposed
|
6 / 8569 (0.07%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
38 / 8569 (0.44%) |
26 / 8574 (0.30%) |
occurrences causally related to treatment / all
|
1 / 40 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic hepatic failure
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug-induced liver injury
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder cholesterolosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder perforation
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder polyp
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cirrhosis
|
|
|
subjects affected / exposed
|
11 / 8569 (0.13%) |
7 / 8574 (0.08%) |
occurrences causally related to treatment / all
|
2 / 13 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Hepatic cyst
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic failure
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hepatic fibrosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic mass
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic steatosis
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis acute
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatorenal syndrome
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocholecystis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic hepatitis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaundice
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver injury
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-alcoholic steatohepatitis
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Porcelain gallbladder
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Portal vein thrombosis
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Anticoagulation drug level below therapeutic
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatine phosphokinase increased
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood glucose abnormal
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood glucose increased
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure increased
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure decreased
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheterisation cardiac
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain natriuretic peptide increased
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General physical condition abnormal
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Glomerular filtration rate decreased
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
International normalised ratio increased
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver function test increased
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transaminases increased
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Troponin increased
|
|
|
subjects affected / exposed
|
7 / 8569 (0.08%) |
11 / 8574 (0.13%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urine cytology abnormal
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Weight decreased
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram QT prolonged
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram ST segment elevation
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis C antibody positive
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Troponin I increased
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Troponin T increased
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
Abdominal injury
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall wound
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wound dehiscence
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Accidental overdose
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Accidental poisoning
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol poisoning
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Allergic transfusion reaction
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia postoperative
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anastomotic leak
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anastomotic ulcer
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
subjects affected / exposed
|
14 / 8569 (0.16%) |
19 / 8574 (0.22%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial bypass occlusion
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial injury
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial restenosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back injury
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone contusion
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain contusion
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac procedure complication
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiac valve replacement complication
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery restenosis
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cartilage injury
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract operation complication
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical vertebral fracture
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cement embolism
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest crushing
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Chest injury
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clavicle fracture
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complications of transplanted liver
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Compression fracture
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Concussion
|
|
|
subjects affected / exposed
|
7 / 8569 (0.08%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Contusion
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Confusion postoperative
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery restenosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary bypass stenosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Costal cartilage fracture
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
Cystitis radiation
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Exposure to toxic agent
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extradural haematoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eyelid injury
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
10 / 8574 (0.12%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
subjects affected / exposed
|
9 / 8569 (0.11%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
subjects affected / exposed
|
20 / 8569 (0.23%) |
14 / 8574 (0.16%) |
occurrences causally related to treatment / all
|
1 / 20 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
subjects affected / exposed
|
18 / 8569 (0.21%) |
16 / 8574 (0.19%) |
occurrences causally related to treatment / all
|
1 / 18 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foreign body in gastrointestinal tract
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foreign body in respiratory tract
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture displacement
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fractured sacrum
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gun shot wound
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Haematuria traumatic
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hand fracture
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heat stroke
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head injury
|
|
|
subjects affected / exposed
|
8 / 8569 (0.09%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Hip fracture
|
|
|
subjects affected / exposed
|
15 / 8569 (0.18%) |
13 / 8574 (0.15%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ilium fracture
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
subjects affected / exposed
|
20 / 8569 (0.23%) |
11 / 8574 (0.13%) |
occurrences causally related to treatment / all
|
2 / 20 |
1 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Incisional hernia
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
6 / 8574 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intentional overdose
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaw fracture
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint injury
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laceration
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament rupture
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament sprain
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb crushing injury
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb fracture
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb injury
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
7 / 8574 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb traumatic amputation
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lisfranc fracture
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
subjects affected / exposed
|
9 / 8569 (0.11%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
subjects affected / exposed
|
6 / 8569 (0.07%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
6 / 8574 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple fractures
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple injuries
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle strain
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle rupture
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve injury
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ocular procedural complication
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Overdose
|
|
|
subjects affected / exposed
|
6 / 8569 (0.07%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Patella fracture
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periorbital haematoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periprocedural myocardial infarction
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery restenosis
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periprosthetic fracture
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax traumatic
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumoconiosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural complication
|
|
|
subjects affected / exposed
|
14 / 8569 (0.16%) |
8 / 8574 (0.09%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Post laminectomy syndrome
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural constipation
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural discharge
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematuria
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
11 / 8574 (0.13%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Post procedural inflammation
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural myocardial infarction
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative ileus
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative delirium
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative respiratory failure
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative thoracic procedure complication
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative thrombosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound complication
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural complication
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural pain
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural pneumothorax
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural shock
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pubis fracture
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiation oesophagitis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal laceration postoperative
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
subjects affected / exposed
|
10 / 8569 (0.12%) |
7 / 8574 (0.08%) |
occurrences causally related to treatment / all
|
0 / 10 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
subjects affected / exposed
|
15 / 8569 (0.18%) |
12 / 8574 (0.14%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
subjects affected / exposed
|
7 / 8569 (0.08%) |
8 / 8574 (0.09%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
Sedation complication
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin abrasion
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin injury
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin wound
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
6 / 8569 (0.07%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skull fractured base
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue injury
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal column injury
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
12 / 8574 (0.14%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic injury
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic rupture
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stab wound
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Sternal fracture
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stoma site haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
subjects affected / exposed
|
9 / 8569 (0.11%) |
6 / 8574 (0.07%) |
occurrences causally related to treatment / all
|
0 / 9 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Subcutaneous haematoma
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
subjects affected / exposed
|
11 / 8569 (0.13%) |
8 / 8574 (0.09%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Subdural haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Tendon injury
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
subjects affected / exposed
|
8 / 8569 (0.09%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thermal burn
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
subjects affected / exposed
|
6 / 8569 (0.07%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
12 / 8574 (0.14%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tongue injury
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transfusion reaction
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transplant dysfunction
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic arthritis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic haemothorax
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic intracranial haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulna fracture
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
8 / 8574 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft occlusion
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft restenosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft thrombosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound haematoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound necrosis
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
6 / 8574 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
Adenomatous polyposis coli
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital hepatobiliary anomaly
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart disease congenital
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocele
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertrophic cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitello-intestinal duct remnant
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis Meckel's
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Acute cardiac event
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Acute coronary syndrome
|
|
|
subjects affected / exposed
|
31 / 8569 (0.36%) |
17 / 8574 (0.20%) |
occurrences causally related to treatment / all
|
0 / 33 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 1 |
Acute left ventricular failure
|
|
|
subjects affected / exposed
|
17 / 8569 (0.20%) |
16 / 8574 (0.19%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Acute myocardial infarction
|
|
|
subjects affected / exposed
|
233 / 8569 (2.72%) |
265 / 8574 (3.09%) |
occurrences causally related to treatment / all
|
7 / 264 |
3 / 293 |
deaths causally related to treatment / all
|
0 / 18 |
0 / 24 |
Angina pectoris
|
|
|
subjects affected / exposed
|
159 / 8569 (1.86%) |
154 / 8574 (1.80%) |
occurrences causally related to treatment / all
|
1 / 175 |
0 / 178 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Angina unstable
|
|
|
subjects affected / exposed
|
269 / 8569 (3.14%) |
271 / 8574 (3.16%) |
occurrences causally related to treatment / all
|
4 / 332 |
2 / 349 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve calcification
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve disease
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve disease mixed
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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 / 8569 (0.01%) |
2 / 8574 (0.02%) |
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
|
2 / 8569 (0.02%) |
10 / 8574 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
subjects affected / exposed
|
6 / 8569 (0.07%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Arteriosclerosis coronary artery
|
|
|
subjects affected / exposed
|
16 / 8569 (0.19%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
1 / 21 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
139 / 8569 (1.62%) |
117 / 8574 (1.36%) |
occurrences causally related to treatment / all
|
3 / 177 |
1 / 138 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Atrial flutter
|
|
|
subjects affected / exposed
|
34 / 8569 (0.40%) |
21 / 8574 (0.24%) |
occurrences causally related to treatment / all
|
0 / 44 |
1 / 25 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial tachycardia
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial thrombosis
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
subjects affected / exposed
|
7 / 8569 (0.08%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
1 / 7 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block complete
|
|
|
subjects affected / exposed
|
14 / 8569 (0.16%) |
19 / 8574 (0.22%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Atrioventricular block second degree
|
|
|
subjects affected / exposed
|
7 / 8569 (0.08%) |
10 / 8574 (0.12%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradyarrhythmia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
21 / 8569 (0.25%) |
16 / 8574 (0.19%) |
occurrences causally related to treatment / all
|
0 / 22 |
1 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bifascicular block
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bundle branch block left
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bundle branch block right
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
subjects affected / exposed
|
31 / 8569 (0.36%) |
33 / 8574 (0.38%) |
occurrences causally related to treatment / all
|
1 / 32 |
1 / 34 |
deaths causally related to treatment / all
|
0 / 19 |
1 / 28 |
Cardiac asthma
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorder
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure
|
|
|
subjects affected / exposed
|
188 / 8569 (2.19%) |
147 / 8574 (1.71%) |
occurrences causally related to treatment / all
|
4 / 252 |
2 / 199 |
deaths causally related to treatment / all
|
0 / 12 |
0 / 24 |
Cardiac failure acute
|
|
|
subjects affected / exposed
|
31 / 8569 (0.36%) |
22 / 8574 (0.26%) |
occurrences causally related to treatment / all
|
0 / 39 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 6 |
Cardiac failure congestive
|
|
|
subjects affected / exposed
|
147 / 8569 (1.72%) |
121 / 8574 (1.41%) |
occurrences causally related to treatment / all
|
4 / 205 |
0 / 177 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 12 |
Cardiac failure chronic
|
|
|
subjects affected / exposed
|
20 / 8569 (0.23%) |
12 / 8574 (0.14%) |
occurrences causally related to treatment / all
|
0 / 23 |
1 / 14 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Cardiac ventricular thrombosis
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac tamponade
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
subjects affected / exposed
|
11 / 8569 (0.13%) |
12 / 8574 (0.14%) |
occurrences causally related to treatment / all
|
1 / 11 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 12 |
Cardiogenic shock
|
|
|
subjects affected / exposed
|
13 / 8569 (0.15%) |
19 / 8574 (0.22%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 14 |
Cardiomegaly
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiomyopathy
|
|
|
subjects affected / exposed
|
8 / 8569 (0.09%) |
7 / 8574 (0.08%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiomyopathy acute
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiopulmonary failure
|
|
|
subjects affected / exposed
|
7 / 8569 (0.08%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 2 |
Cardiovascular insufficiency
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Cardiovascular disorder
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronotropic incompetence
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic left ventricular failure
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Congestive cardiomyopathy
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Conduction disorder
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cor pulmonale
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery aneurysm
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery occlusion
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
9 / 8574 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
subjects affected / exposed
|
84 / 8569 (0.98%) |
106 / 8574 (1.24%) |
occurrences causally related to treatment / all
|
1 / 87 |
5 / 113 |
deaths causally related to treatment / all
|
1 / 3 |
0 / 5 |
Coronary artery stenosis
|
|
|
subjects affected / exposed
|
22 / 8569 (0.26%) |
12 / 8574 (0.14%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery thrombosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Coronary ostial stenosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dressler's syndrome
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diastolic dysfunction
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extrasystoles
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart valve incompetence
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart valve stenosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Left ventricular dysfunction
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic cardiomyopathy
|
|
|
subjects affected / exposed
|
18 / 8569 (0.21%) |
10 / 8574 (0.12%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Left ventricular failure
|
|
|
subjects affected / exposed
|
13 / 8569 (0.15%) |
11 / 8574 (0.13%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
subjects affected / exposed
|
6 / 8569 (0.07%) |
7 / 8574 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve stenosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
subjects affected / exposed
|
108 / 8569 (1.26%) |
96 / 8574 (1.12%) |
occurrences causally related to treatment / all
|
2 / 111 |
1 / 104 |
deaths causally related to treatment / all
|
0 / 24 |
0 / 19 |
Myocarditis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial ischaemia
|
|
|
subjects affected / exposed
|
54 / 8569 (0.63%) |
47 / 8574 (0.55%) |
occurrences causally related to treatment / all
|
0 / 61 |
0 / 49 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 4 |
Nodal arrhythmia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
3 / 8569 (0.04%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
8 / 8574 (0.09%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postinfarction angina
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Prinzmetal angina
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulseless electrical activity
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rheumatic heart disease
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Right ventricular failure
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Sinus arrest
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus node dysfunction
|
|
|
subjects affected / exposed
|
13 / 8569 (0.15%) |
14 / 8574 (0.16%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus tachycardia
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
6 / 8569 (0.07%) |
12 / 8574 (0.14%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachyarrhythmia
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Torsade de pointes
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Trifascicular block
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular arrhythmia
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ventricular extrasystoles
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular failure
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular fibrillation
|
|
|
subjects affected / exposed
|
9 / 8569 (0.11%) |
8 / 8574 (0.09%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 4 |
Ventricular tachycardia
|
|
|
subjects affected / exposed
|
15 / 8569 (0.18%) |
19 / 8574 (0.22%) |
occurrences causally related to treatment / all
|
1 / 21 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Adams-Stokes syndrome
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
Amnesia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Amyotrophic lateral sclerosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Aphasia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arachnoid cyst
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ataxia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Autonomic failure syndrome
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Balance disorder
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal ganglia infarction
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basilar artery perforation
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Brain injury
|
|
|
subjects affected / exposed
|
6 / 8569 (0.07%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Brain oedema
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Brain stem infarction
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
6 / 8574 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain stem haemorrhage
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain stem stroke
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid arteriosclerosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Burning sensation
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery occlusion
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
subjects affected / exposed
|
21 / 8569 (0.25%) |
27 / 8574 (0.31%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 27 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery insufficiency
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid sinus syndrome
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar ataxia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar infarction
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cerebellar stroke
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral artery embolism
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral artery occlusion
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral atrophy
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haematoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
subjects affected / exposed
|
6 / 8569 (0.07%) |
7 / 8574 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Cerebral infarction
|
|
|
subjects affected / exposed
|
32 / 8569 (0.37%) |
24 / 8574 (0.28%) |
occurrences causally related to treatment / all
|
2 / 33 |
1 / 27 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 4 |
Cerebral ischaemia
|
|
|
subjects affected / exposed
|
9 / 8569 (0.11%) |
6 / 8574 (0.07%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
subjects affected / exposed
|
88 / 8569 (1.03%) |
102 / 8574 (1.19%) |
occurrences causally related to treatment / all
|
3 / 94 |
2 / 112 |
deaths causally related to treatment / all
|
0 / 11 |
0 / 10 |
Cerebrovascular disorder
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular insufficiency
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical cord compression
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical radiculopathy
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervicobrachial syndrome
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cluster headache
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cranial nerve palsies multiple
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Demyelinating polyneuropathy
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic autonomic neuropathy
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic hyperosmolar coma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic neuropathy
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness
|
|
|
subjects affected / exposed
|
9 / 8569 (0.11%) |
14 / 8574 (0.16%) |
occurrences causally related to treatment / all
|
1 / 9 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness postural
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysarthria
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dystonic tremor
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolic stroke
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
subjects affected / exposed
|
8 / 8569 (0.09%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Essential tremor
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial paralysis
|
|
|
subjects affected / exposed
|
8 / 8569 (0.09%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial paresis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Focal dyscognitive seizures
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised tonic-clonic seizure
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic cerebral infarction
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic stroke
|
|
|
subjects affected / exposed
|
11 / 8569 (0.13%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
Haemorrhagic transformation stroke
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Headache
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemianopia homonymous
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocephalus
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic encephalopathy
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hypoaesthesia
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive encephalopathy
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic unconsciousness
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic encephalopathy
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokinesia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxic-ischaemic encephalopathy
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Intensive care unit acquired weakness
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracranial aneurysm
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Intraventricular haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Ischaemic cerebral infarction
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic neuropathy
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
subjects affected / exposed
|
90 / 8569 (1.05%) |
97 / 8574 (1.13%) |
occurrences causally related to treatment / all
|
0 / 99 |
2 / 105 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 6 |
Lacunar infarction
|
|
|
subjects affected / exposed
|
14 / 8569 (0.16%) |
8 / 8574 (0.09%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lateral medullary syndrome
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lacunar stroke
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar radiculopathy
|
|
|
subjects affected / exposed
|
6 / 8569 (0.07%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
subjects affected / exposed
|
6 / 8569 (0.07%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lumbosacral radiculopathy
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medication overuse headache
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Memory impairment
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
3 / 8569 (0.04%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Migraine
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple system atrophy
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myasthenia gravis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle contractions involuntary
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelopathy
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve compression
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorder
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurological symptom
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurodegenerative disorder
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normal pressure hydrocephalus
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Occipital neuralgia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraparesis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraesthesia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parkinson's disease
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Partial seizures
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peroneal nerve palsy
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyneuropathy
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post herpetic neuralgia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Presyncope
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postictal paralysis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Quadriplegia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radicular syndrome
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiculopathy
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ruptured cerebral aneurysm
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Sciatica
|
|
|
subjects affected / exposed
|
7 / 8569 (0.08%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seizure
|
|
|
subjects affected / exposed
|
10 / 8569 (0.12%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
1 / 10 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Simple partial seizures
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Somnolence
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal claudication
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylitic myelopathy
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stiff person syndrome
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural hygroma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stroke in evolution
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Syncope
|
|
|
subjects affected / exposed
|
41 / 8569 (0.48%) |
37 / 8574 (0.43%) |
occurrences causally related to treatment / all
|
2 / 44 |
3 / 38 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thalamic infarction
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thoracic outlet syndrome
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tension headache
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombotic stroke
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Thrombotic cerebral infarction
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic neuropathy
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tremor
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
54 / 8569 (0.63%) |
68 / 8574 (0.79%) |
occurrences causally related to treatment / all
|
1 / 59 |
1 / 76 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Vascular encephalopathy
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular dementia
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral artery stenosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vocal cord paralysis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebrobasilar insufficiency
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia Alzheimer's type
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia with Lewy bodies
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
IIIrd nerve paralysis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VIth nerve paralysis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VIth nerve paresis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo CNS origin
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wernicke-Korsakoff syndrome
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
|
|
Agranulocytosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia
|
|
|
subjects affected / exposed
|
28 / 8569 (0.33%) |
20 / 8574 (0.23%) |
occurrences causally related to treatment / all
|
0 / 30 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia of chronic disease
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coagulopathy
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Disseminated intravascular coagulation
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Elephantiasis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hilar lymphadenopathy
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
4 / 8569 (0.05%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Febrile neutropenia
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune thrombocytopenic purpura
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
18 / 8569 (0.21%) |
12 / 8574 (0.14%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenopathy
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenopathy mediastinal
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normocytic anaemia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Microcytic anaemia
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasmacytosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic cyst
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic infarction
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytopenic purpura
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia vitamin B12 deficiency
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
Acute vestibular syndrome
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deafness neurosensory
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoacusis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden hearing loss
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tinnitus
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo
|
|
|
subjects affected / exposed
|
12 / 8569 (0.14%) |
11 / 8574 (0.13%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo labyrinthine
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
subjects affected / exposed
|
8 / 8569 (0.09%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular ataxia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular disorder
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Amaurosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Amblyopia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Amaurosis fugax
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blindness transient
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Astigmatism
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract
|
|
|
subjects affected / exposed
|
26 / 8569 (0.30%) |
28 / 8574 (0.33%) |
occurrences causally related to treatment / all
|
0 / 32 |
0 / 31 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract nuclear
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract subcapsular
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Corneal deposits
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dacryostenosis acquired
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic retinal oedema
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic retinopathy
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diplopia
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine ophthalmopathy
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Exophthalmos
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glaucoma
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iridocyclitis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iritis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lagophthalmos
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular fibrosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular degeneration
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular oedema
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Maculopathy
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal artery occlusion
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal tear
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal vascular occlusion
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tractional retinal detachment
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal vein occlusion
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulcerative keratitis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vision blurred
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual impairment
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
6 / 8569 (0.07%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tolosa-Hunt syndrome
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Abdominal discomfort
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal adhesions
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal incarcerated hernia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal hernia
|
|
|
subjects affected / exposed
|
7 / 8569 (0.08%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal hernia obstructive
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain lower
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
subjects affected / exposed
|
9 / 8569 (0.11%) |
13 / 8574 (0.15%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute haemorrhagic ulcerative colitis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcoholic pancreatitis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fissure
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ascites
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fistula
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Barrett's oesophagus
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
subjects affected / exposed
|
11 / 8569 (0.13%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis microscopic
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
7 / 8574 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Constipation
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
13 / 8574 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ulcerative
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gastroenteropathy
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gastroparesis
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dieulafoy's vascular malformation
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
subjects affected / exposed
|
11 / 8569 (0.13%) |
10 / 8574 (0.12%) |
occurrences causally related to treatment / all
|
1 / 11 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer perforation
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenitis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocutaneous fistula
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterovesical fistula
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (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
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epiploic appendagitis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Faecaloma
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Faeces discoloured
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Food poisoning
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric haemorrhage
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gastric perforation
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric polyps
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric stenosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
11 / 8569 (0.13%) |
9 / 8574 (0.10%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
20 / 8569 (0.23%) |
13 / 8574 (0.15%) |
occurrences causally related to treatment / all
|
1 / 20 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroduodenitis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal angiodysplasia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
18 / 8569 (0.21%) |
17 / 8574 (0.20%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal inflammation
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal necrosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal obstruction
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal perforation
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
subjects affected / exposed
|
10 / 8569 (0.12%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gingival bleeding
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematochezia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hernial eventration
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus paralytic
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired gastric emptying
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated umbilical hernia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
subjects affected / exposed
|
13 / 8569 (0.15%) |
10 / 8574 (0.12%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal fibrosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal infarction
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Intestinal ischaemia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal polyp
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal pseudo-obstruction
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intra-abdominal fluid collection
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jejunal perforation
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intra-abdominal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Intussusception
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestinal ulcer
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestinal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
subjects affected / exposed
|
9 / 8569 (0.11%) |
12 / 8574 (0.14%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lumbar hernia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melaena
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric artery embolism
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Mesenteric artery stenosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nausea
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric panniculitis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric vascular insufficiency
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Obstruction gastric
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive pancreatitis
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Odynophagia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal food impaction
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal obstruction
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal perforation
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal ulcer
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal varices haemorrhage
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic cyst
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis ulcerative
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Palatal oedema
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic duct obstruction
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic necrosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
subjects affected / exposed
|
12 / 8569 (0.14%) |
12 / 8574 (0.14%) |
occurrences causally related to treatment / all
|
1 / 12 |
1 / 12 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pancreatitis acute
|
|
|
subjects affected / exposed
|
15 / 8569 (0.18%) |
13 / 8574 (0.15%) |
occurrences causally related to treatment / all
|
1 / 17 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pancreatitis relapsing
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis chronic
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis necrotising
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer haemorrhage
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatolithiasis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periodontal disease
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal adhesions
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Proctitis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumoperitoneum
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Portal hypertensive gastropathy
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
2 / 8569 (0.02%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal haematoma
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Retroperitoneal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland cyst
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
subjects affected / exposed
|
9 / 8569 (0.11%) |
10 / 8574 (0.12%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestine ulcer
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal perforation
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Steatorrhoea
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis mesenteric vessel
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Umbilical hernia
|
|
|
subjects affected / exposed
|
9 / 8569 (0.11%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vomiting
|
|
|
subjects affected / exposed
|
9 / 8569 (0.11%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varices oesophageal
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Upper gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
8 / 8569 (0.09%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Mallory-Weiss syndrome
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Actinic keratosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angioedema
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decubitus ulcer
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermal cyst
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis contact
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic bullosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot
|
|
|
subjects affected / exposed
|
29 / 8569 (0.34%) |
37 / 8574 (0.43%) |
occurrences causally related to treatment / all
|
0 / 34 |
0 / 45 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ulcer
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eczema
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erythema multiforme
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fixed eruption
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hidradenitis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypersensitivity vasculitis
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic skin ulcer
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Keloid scar
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lichen planus
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lichen sclerosus
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melanocytic hyperplasia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathic ulcer
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Purpura
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyoderma gangrenosum
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin swelling
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
23 / 8569 (0.27%) |
24 / 8574 (0.28%) |
occurrences causally related to treatment / all
|
0 / 26 |
1 / 28 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stasis dermatitis
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic skin eruption
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urticaria
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Henoch-Schonlein purpura
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
Acute kidney injury
|
|
|
subjects affected / exposed
|
127 / 8569 (1.48%) |
94 / 8574 (1.10%) |
occurrences causally related to treatment / all
|
21 / 152 |
10 / 96 |
deaths causally related to treatment / all
|
1 / 6 |
1 / 4 |
Azotaemia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder disorder
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder outlet obstruction
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder perforation
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder mass
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder prolapse
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus urethral
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus bladder
|
|
|
subjects affected / exposed
|
6 / 8569 (0.07%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Calculus urinary
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
subjects affected / exposed
|
13 / 8569 (0.15%) |
9 / 8574 (0.10%) |
occurrences causally related to treatment / all
|
1 / 17 |
1 / 10 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Cystitis glandularis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis noninfective
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis ulcerative
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
End stage renal disease
|
|
|
subjects affected / exposed
|
7 / 8569 (0.08%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
1 / 3 |
0 / 0 |
Dysuria
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic nephropathy
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Glomerulonephritis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
16 / 8569 (0.19%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
6 / 8569 (0.07%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower urinary tract symptoms
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myeloma cast nephropathy
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ketonuria
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
18 / 8569 (0.21%) |
14 / 8574 (0.16%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedematous kidney
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrotic syndrome
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvi-ureteric obstruction
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Proteinuria
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pollakiuria
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery stenosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal colic
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cyst
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cyst ruptured
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal disorder
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure
|
|
|
subjects affected / exposed
|
17 / 8569 (0.20%) |
10 / 8574 (0.12%) |
occurrences causally related to treatment / all
|
1 / 17 |
2 / 11 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Renal haematoma
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
subjects affected / exposed
|
12 / 8569 (0.14%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
2 / 12 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal infarct
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal injury
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal tubular acidosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal tubular necrosis
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress urinary incontinence
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric stenosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureterolithiasis
|
|
|
subjects affected / exposed
|
17 / 8569 (0.20%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
1 / 21 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral meatus stenosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral obstruction
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
5 / 8569 (0.06%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary bladder haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary bladder polyp
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
subjects affected / exposed
|
10 / 8569 (0.12%) |
8 / 8574 (0.09%) |
occurrences causally related to treatment / all
|
1 / 10 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Adrenal insufficiency
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal mass
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenomegaly
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basedow's disease
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Goitre
|
|
|
subjects affected / exposed
|
8 / 8569 (0.09%) |
7 / 8574 (0.08%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperadrenalism
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperparathyroidism
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypopituitarism
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperparathyroidism primary
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic nodular goitre
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Arthritis
|
|
|
subjects affected / exposed
|
9 / 8569 (0.11%) |
14 / 8574 (0.16%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthralgia
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
7 / 8574 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Articular calcification
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis reactive
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical spinal stenosis
|
|
|
subjects affected / exposed
|
6 / 8569 (0.07%) |
6 / 8574 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back pain
|
|
|
subjects affected / exposed
|
9 / 8569 (0.11%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondromalacia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondropathy
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Compartment syndrome
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diastasis recti abdominis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Costochondritis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dupuytren's contracture
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extraskeletal ossification
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Flank pain
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facet joint syndrome
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fasciitis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture malunion
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture nonunion
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gouty arthritis
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemarthrosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc compression
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc degeneration
|
|
|
subjects affected / exposed
|
6 / 8569 (0.07%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc disorder
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc displacement
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
17 / 8569 (0.20%) |
24 / 8574 (0.28%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaw cyst
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament calcification
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint ankylosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint contracture
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniscal degeneration
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
18 / 8569 (0.21%) |
14 / 8574 (0.16%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle fibrosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mobility decreased
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle spasms
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
subjects affected / exposed
|
6 / 8569 (0.07%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
24 / 8569 (0.28%) |
12 / 8574 (0.14%) |
occurrences causally related to treatment / all
|
0 / 25 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myalgia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
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
|
3 / 8569 (0.04%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathic arthropathy
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myositis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteochondrosis
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteitis
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
subjects affected / exposed
|
92 / 8569 (1.07%) |
103 / 8574 (1.20%) |
occurrences causally related to treatment / all
|
0 / 102 |
1 / 114 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoporosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteolysis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoporotic fracture
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in jaw
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periarthritis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pathological fracture
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Patellofemoral pain syndrome
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyarthritis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polymyalgia rheumatica
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudarthrosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rheumatoid arthritis
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
7 / 8574 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Rhabdomyolysis
|
|
|
subjects affected / exposed
|
7 / 8569 (0.08%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psoriatic arthropathy
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sjogren's syndrome
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal column stenosis
|
|
|
subjects affected / exposed
|
12 / 8569 (0.14%) |
11 / 8574 (0.13%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
subjects affected / exposed
|
16 / 8569 (0.19%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal ligament ossification
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
3 / 8569 (0.04%) |
9 / 8574 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylitis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal pain
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendonitis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Synovial cyst
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tenosynovitis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Trigger finger
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tenosynovitis stenosans
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral lesion
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immunoglobulin G4 related disease
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal sepsis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Abdominal wall abscess
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
subjects affected / exposed
|
9 / 8569 (0.11%) |
8 / 8574 (0.09%) |
occurrences causally related to treatment / all
|
1 / 10 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acquired immunodeficiency syndrome
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute endocarditis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute sinusitis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Amoebiasis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendiceal abscess
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
subjects affected / exposed
|
12 / 8569 (0.14%) |
12 / 8574 (0.14%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis perforated
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
subjects affected / exposed
|
11 / 8569 (0.13%) |
6 / 8574 (0.07%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis infective
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aspergilloma
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atypical pneumonia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
6 / 8574 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterascites
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial colitis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial sepsis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial tracheitis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacteriuria
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Beta haemolytic streptococcal infection
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary sepsis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Bone abscess
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain abscess
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast abscess
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
subjects affected / exposed
|
35 / 8569 (0.41%) |
15 / 8574 (0.17%) |
occurrences causally related to treatment / all
|
0 / 35 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis bacterial
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis viral
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Burn infection
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis infective
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Campylobacter gastroenteritis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
subjects affected / exposed
|
93 / 8569 (1.09%) |
84 / 8574 (0.98%) |
occurrences causally related to treatment / all
|
2 / 117 |
0 / 100 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis gangrenous
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis of male external genital organ
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis orbital
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis staphylococcal
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Central nervous system infection
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest wall abscess
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis infective
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
6 / 8574 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Chronic sinusitis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridial sepsis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Clostridium difficile colitis
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
7 / 8574 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile infection
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cystitis
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
9 / 8574 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cytomegalovirus viraemia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dengue fever
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot infection
|
|
|
subjects affected / exposed
|
13 / 8569 (0.15%) |
10 / 8574 (0.12%) |
occurrences causally related to treatment / all
|
0 / 13 |
1 / 11 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Device related infection
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gangrene
|
|
|
subjects affected / exposed
|
11 / 8569 (0.13%) |
7 / 8574 (0.08%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea infectious
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
subjects affected / exposed
|
20 / 8569 (0.23%) |
20 / 8574 (0.23%) |
occurrences causally related to treatment / all
|
0 / 22 |
1 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalitis
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Encephalomyelitis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
2 / 8569 (0.02%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Endocarditis bacterial
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Endocarditis enterococcal
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis staphylococcal
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometritis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis infectious
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterococcal bacteraemia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterococcal sepsis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epididymitis
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epiglottitis
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia bacteraemia
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
subjects affected / exposed
|
13 / 8569 (0.15%) |
11 / 8574 (0.13%) |
occurrences causally related to treatment / all
|
0 / 13 |
1 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
External ear cellulitis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extradural abscess
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fungal infection
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
30 / 8569 (0.35%) |
22 / 8574 (0.26%) |
occurrences causally related to treatment / all
|
0 / 40 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gas gangrene
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric infection
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
27 / 8569 (0.32%) |
26 / 8574 (0.30%) |
occurrences causally related to treatment / all
|
0 / 27 |
2 / 27 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis norovirus
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis rotavirus
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis salmonella
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin abscess
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Giardiasis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Helicobacter infection
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma infection
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis viral
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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 / 8569 (0.04%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Human anaplasmosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implant site infection
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
3 / 8569 (0.04%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection
|
|
|
subjects affected / exposed
|
6 / 8569 (0.07%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infectious colitis
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective exacerbation of chronic obstructive airways disease
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective gastroduodenitis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza
|
|
|
subjects affected / exposed
|
15 / 8569 (0.18%) |
17 / 8574 (0.20%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral discitis
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Klebsiella bacteraemia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Klebsiella sepsis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Legionella infection
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver abscess
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Localised infection
|
|
|
subjects affected / exposed
|
10 / 8569 (0.12%) |
16 / 8574 (0.19%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
10 / 8569 (0.12%) |
9 / 8574 (0.10%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung abscess
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung infection
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lyme disease
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mastitis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malaria
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mastoiditis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mediastinitis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device site abscess
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device site infection
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device site joint infection
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis aseptic
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis pneumococcal
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Meningitis viral
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mucormycosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle abscess
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrotising fasciitis
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurosyphilis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenic sepsis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal candidiasis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Onychomycosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oral candidiasis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orchitis
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oropharyngeal candidiasis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
subjects affected / exposed
|
39 / 8569 (0.46%) |
26 / 8574 (0.30%) |
occurrences causally related to treatment / all
|
1 / 46 |
0 / 35 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis acute
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis chronic
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis externa
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis media
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis media chronic
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic abscess
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parainfluenzae virus infection
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parotitis
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic abscess
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic inflammatory disease
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perineal abscess
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Perinephric abscess
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Peritonitis bacterial
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonsillar abscess
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngitis
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleurisy viral
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumococcal infection
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pneumococcal sepsis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
subjects affected / exposed
|
219 / 8569 (2.56%) |
194 / 8574 (2.26%) |
occurrences causally related to treatment / all
|
3 / 246 |
2 / 212 |
deaths causally related to treatment / all
|
1 / 21 |
0 / 10 |
Pneumonia bacterial
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pneumonia pneumococcal
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia respiratory syncytial viral
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia staphylococcal
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia streptococcal
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia viral
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural cellulitis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural infection
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
9 / 8574 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative abscess
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
subjects affected / exposed
|
13 / 8569 (0.15%) |
11 / 8574 (0.13%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic abscess
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary sepsis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulmonary tuberculosis
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelitis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
14 / 8569 (0.16%) |
14 / 8574 (0.16%) |
occurrences causally related to treatment / all
|
9 / 15 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
subjects affected / exposed
|
15 / 8569 (0.18%) |
10 / 8574 (0.12%) |
occurrences causally related to treatment / all
|
5 / 15 |
3 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis chronic
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Rectal abscess
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal abscess
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory syncytial virus bronchiolitis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory syncytial virus bronchitis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory syncytial virus infection
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Retroperitoneal abscess
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhinitis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rickettsiosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rotavirus infection
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salmonella bacteraemia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scrotal abscess
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scrub typhus
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
70 / 8569 (0.82%) |
77 / 8574 (0.90%) |
occurrences causally related to treatment / all
|
2 / 71 |
3 / 84 |
deaths causally related to treatment / all
|
0 / 10 |
0 / 14 |
Sepsis syndrome
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Septic arthritis staphylococcal
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Septic shock
|
|
|
subjects affected / exposed
|
24 / 8569 (0.28%) |
21 / 8574 (0.24%) |
occurrences causally related to treatment / all
|
1 / 27 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 7 |
Sinusitis
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinusitis fungal
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin bacterial infection
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin infection
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic abscess
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal abscess
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal bacteraemia
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal infection
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcal abscess
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcal sepsis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Streptococcal bacteraemia
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tick-borne fever
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsillitis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth abscess
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth infection
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheitis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheobronchitis
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tuberculosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (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
|
5 / 8569 (0.06%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
67 / 8569 (0.78%) |
49 / 8574 (0.57%) |
occurrences causally related to treatment / all
|
20 / 71 |
15 / 53 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection bacterial
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection enterococcal
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
subjects affected / exposed
|
25 / 8569 (0.29%) |
22 / 8574 (0.26%) |
occurrences causally related to treatment / all
|
9 / 26 |
9 / 23 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
Vestibular neuronitis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viraemia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral infection
|
|
|
subjects affected / exposed
|
7 / 8569 (0.08%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 8 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral sinusitis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral myocarditis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral upper respiratory tract infection
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound abscess
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection pseudomonas
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection
|
|
|
subjects affected / exposed
|
10 / 8569 (0.12%) |
11 / 8574 (0.13%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Acute hepatitis B
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic hepatitis C
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
H1N1 influenza
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HIV infection
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HIV-associated neurocognitive disorder
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis A
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis B
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
2 / 8574 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis E
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
West Nile viral infection
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (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
|
|
|
Adult failure to thrive
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcoholic ketoacidosis
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dehydration
|
|
|
subjects affected / exposed
|
19 / 8569 (0.22%) |
20 / 8574 (0.23%) |
occurrences causally related to treatment / all
|
1 / 19 |
1 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decreased appetite
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
subjects affected / exposed
|
13 / 8569 (0.15%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
1 / 13 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus inadequate control
|
|
|
subjects affected / exposed
|
29 / 8569 (0.34%) |
14 / 8574 (0.16%) |
occurrences causally related to treatment / all
|
2 / 34 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes with hyperosmolarity
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic complication
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
subjects affected / exposed
|
23 / 8569 (0.27%) |
27 / 8574 (0.31%) |
occurrences causally related to treatment / all
|
2 / 27 |
2 / 29 |
deaths causally related to treatment / all
|
1 / 2 |
0 / 0 |
Diabetic ketosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic metabolic decompensation
|
|
|
subjects affected / exposed
|
27 / 8569 (0.32%) |
17 / 8574 (0.20%) |
occurrences causally related to treatment / all
|
0 / 35 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrolyte imbalance
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Euglycaemic diabetic ketoacidosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Failure to thrive
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gout
|
|
|
subjects affected / exposed
|
6 / 8569 (0.07%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fluid retention
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fluid overload
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
55 / 8569 (0.64%) |
37 / 8574 (0.43%) |
occurrences causally related to treatment / all
|
1 / 56 |
0 / 49 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemic hyperosmolar nonketotic syndrome
|
|
|
subjects affected / exposed
|
5 / 8569 (0.06%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
subjects affected / exposed
|
6 / 8569 (0.07%) |
6 / 8574 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
2 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperlipidaemia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypernatraemia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertriglyceridaemia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperuricaemia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypocalcaemia
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
86 / 8569 (1.00%) |
69 / 8574 (0.80%) |
occurrences causally related to treatment / all
|
19 / 101 |
23 / 86 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
5 / 8574 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypomagnesaemia
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
subjects affected / exposed
|
4 / 8569 (0.05%) |
14 / 8574 (0.16%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
9 / 8569 (0.11%) |
9 / 8574 (0.10%) |
occurrences causally related to treatment / all
|
0 / 9 |
1 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ketoacidosis
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
7 / 8574 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
2 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ketosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lactic acidosis
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Latent autoimmune diabetes in adults
|
|
|
subjects affected / exposed
|
1 / 8569 (0.01%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
0 / 8574 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lipomatosis
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obesity
|
|
|
subjects affected / exposed
|
8 / 8569 (0.09%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic acidosis
|
|
|
subjects affected / exposed
|
3 / 8569 (0.04%) |
3 / 8574 (0.03%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 1 diabetes mellitus
|
|
|
subjects affected / exposed
|
2 / 8569 (0.02%) |
4 / 8574 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
subjects affected / exposed
|
7 / 8569 (0.08%) |
7 / 8574 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitamin D deficiency
|
|
|
subjects affected / exposed
|
0 / 8569 (0.00%) |
1 / 8574 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |