Serious adverse events
|
Participants Who Had Received Placebo During the 018 Study |
Participants Who Had Received Odanacatib During the 018 Study |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
2566 / 8028 (31.96%) |
2528 / 8043 (31.43%) |
number of deaths (all causes)
|
341 |
388 |
number of deaths resulting from adverse events
|
1 |
1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Adenocarcinoma of colon
|
|
|
subjects affected / exposed
|
7 / 8028 (0.09%) |
11 / 8043 (0.14%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Angiosarcoma metastatic
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
subjects affected / exposed
|
76 / 8028 (0.95%) |
83 / 8043 (1.03%) |
occurrences causally related to treatment / all
|
0 / 92 |
0 / 98 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain neoplasm
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer
|
|
|
subjects affected / exposed
|
33 / 8028 (0.41%) |
35 / 8043 (0.44%) |
occurrences causally related to treatment / all
|
0 / 33 |
0 / 35 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Colon cancer
|
|
|
subjects affected / exposed
|
17 / 8028 (0.21%) |
24 / 8043 (0.30%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
Colorectal cancer
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diffuse large B-cell lymphoma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal carcinoma
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Invasive ductal breast carcinoma
|
|
|
subjects affected / exposed
|
8 / 8028 (0.10%) |
7 / 8043 (0.09%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Keratoacanthoma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
7 / 8043 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to lung
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastases to lymph nodes
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastatic squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ovarian cancer
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
8 / 8043 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Ovarian epithelial cancer
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pancreatic carcinoma
|
|
|
subjects affected / exposed
|
9 / 8028 (0.11%) |
14 / 8043 (0.17%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 8 |
Plasma cell myeloma
|
|
|
subjects affected / exposed
|
6 / 8028 (0.07%) |
7 / 8043 (0.09%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal adenoma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland cancer
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin cancer
|
|
|
subjects affected / exposed
|
7 / 8028 (0.09%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
subjects affected / exposed
|
13 / 8028 (0.16%) |
14 / 8043 (0.17%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Squamous cell carcinoma of skin
|
|
|
subjects affected / exposed
|
11 / 8028 (0.14%) |
18 / 8043 (0.22%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid cancer
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid neoplasm
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine cancer
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute leukaemia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
3 / 8028 (0.04%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Adenocarcinoma gastric
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Adenocarcinoma of the cervix
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal cancer
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angiosarcoma
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
B-cell lymphoma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Benign breast neoplasm
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign gastric neoplasm
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign lung neoplasm
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign muscle neoplasm
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of bladder
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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 thyroid gland
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign salivary gland neoplasm
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign vulval neoplasm
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct cancer
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Bladder neoplasm
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone cancer
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone neoplasm
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Borderline mucinous tumour of ovary
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bowen's disease
|
|
|
subjects affected / exposed
|
6 / 8028 (0.07%) |
6 / 8043 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Breast cancer in situ
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Breast cancer recurrent
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer stage III
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast neoplasm
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchial carcinoma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchioloalveolar carcinoma
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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 stomach
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carcinoma in situ of skin
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar tumour
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellopontine angle tumour
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervix cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cervix carcinoma
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
6 / 8043 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervix carcinoma stage II
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangiocarcinoma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Choroid melanoma
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
5 / 8028 (0.06%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clear cell endometrial carcinoma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon adenoma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer metastatic
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Colon neoplasm
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Colorectal cancer recurrent
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ductal adenocarcinoma of pancreas
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal neoplasm
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysplastic naevus
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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
|
1 / 8028 (0.01%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial cancer
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Essential thrombocythaemia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fallopian tube cancer
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Female reproductive neoplasm
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Fibroadenoma of breast
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibroma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibromatosis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Follicle centre lymphoma, follicular grade I, II, III stage II
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gallbladder cancer
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 2 |
Gastric cancer
|
|
|
subjects affected / exposed
|
6 / 8028 (0.07%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
Gastric cancer stage IV
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gastric neoplasm
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gastrointestinal neoplasm
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal stromal tumour
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal tract adenoma
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gingival cancer
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glioblastoma
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Glioblastoma multiforme
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glomus tumour
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemangioma of bone
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cancer
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 4 |
Hepatic neoplasm
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hepatocellular carcinoma
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Inflammatory carcinoma of the breast
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Intraductal papilloma of breast
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraductal proliferative breast lesion
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraocular melanoma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive breast carcinoma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive lobular breast carcinoma
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kaposi's sarcoma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leiomyoma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leiomyosarcoma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lentigo maligna
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukaemia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lip and/or oral cavity cancer
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lip squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lipoma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liposarcoma
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lobular breast carcinoma in situ
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
8 / 8043 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 4 |
Lung adenocarcinoma stage I
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma stage IV
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung cancer metastatic
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Lung carcinoma cell type unspecified stage IV
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lung neoplasm
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung neoplasm malignant
|
|
|
subjects affected / exposed
|
23 / 8028 (0.29%) |
13 / 8043 (0.16%) |
occurrences causally related to treatment / all
|
0 / 24 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 6 |
Lymphangioma
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
2 / 8028 (0.02%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lymphoproliferative disorder
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma in situ
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant neoplasm of ampulla of Vater
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant neoplasm of eyelid
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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 renal pelvis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Malignant neoplasm of unknown primary site
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Malignant neoplasm progression
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Malignant peritoneal neoplasm
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mantle cell lymphoma
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medullary thyroid cancer
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melanocytic naevus
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melanoma recurrent
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
4 / 8028 (0.05%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesothelioma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Mesothelioma malignant
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metaplastic breast carcinoma
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to bone
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastases to central nervous system
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to liver
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Metastases to peritoneum
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to pleura
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to skin
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastasis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastatic bronchial carcinoma
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastatic gastric cancer
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastatic neoplasm
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Metastatic salivary gland cancer
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic uterine cancer
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mucinous breast carcinoma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mycosis fungoides
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelodysplastic syndrome transformation
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myeloproliferative disorder
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal cavity cancer
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Nasal neoplasm
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasopharyngeal cancer
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm malignant
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Neuroendocrine carcinoma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Neuroendocrine carcinoma metastatic
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Non-small cell lung cancer
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-small cell lung cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Non-small cell lung cancer stage IV
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Oesophageal carcinoma
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Oesophageal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oligodendroglioma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Osteoma
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteosarcoma
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ovarian adenoma
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ovarian epithelial cancer stage I
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic carcinoma metastatic
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Pancreatic carcinoma stage IV
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic neoplasm
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Papillary serous endometrial carcinoma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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
|
5 / 8028 (0.06%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papilloma
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parathyroid tumour benign
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic neoplasm
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal mesothelioma malignant
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasmacytoma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Rectal cancer
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal neoplasm
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectosigmoid cancer
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Refractory anaemia with an excess of blasts
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Refractory cytopenia with unilineage dysplasia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cell carcinoma stage II
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal neoplasm
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal oncocytoma
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal cancer
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sarcoma
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Schwannoma
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small cell lung cancer
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 4 |
Small cell lung cancer limited stage
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue neoplasm
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal cord neoplasm
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Splenic marginal zone lymphoma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of lung
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the cervix
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the oral cavity
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Squamous cell carcinoma of the tongue
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Superficial spreading melanoma stage unspecified
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
T-cell lymphoma
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Thymoma malignant
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tongue neoplasm malignant stage unspecified
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsil cancer
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transitional cell cancer of the renal pelvis and ureter
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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
|
3 / 8028 (0.04%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ureteric cancer
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral cancer
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
7 / 8043 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine neoplasm
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulval cancer
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulval cancer stage 0
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Aortic stenosis
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
10 / 8028 (0.12%) |
17 / 8043 (0.21%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hypertension
|
|
|
subjects affected / exposed
|
41 / 8028 (0.51%) |
32 / 8043 (0.40%) |
occurrences causally related to treatment / all
|
0 / 43 |
1 / 36 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypertensive emergency
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral embolism
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
3 / 8028 (0.04%) |
9 / 8043 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis limb
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Accelerated hypertension
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic aneurysm
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
8 / 8043 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Aortic aneurysm rupture
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Aortic arteriosclerosis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic disorder
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic dissection
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Arterial disorder
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial stenosis
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Bleeding varicose vein
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Distributive shock
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Essential hypertension
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extremity necrosis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Femoral artery occlusion
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (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
|
0 / 8028 (0.00%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hot flush
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
subjects affected / exposed
|
20 / 8028 (0.25%) |
10 / 8043 (0.12%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypotension
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
7 / 8043 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hypovolaemic shock
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Iliac artery occlusion
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infarction
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intermittent claudication
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant hypertension
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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
|
4 / 8028 (0.05%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
7 / 8043 (0.09%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral circulatory failure
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral vascular disorder
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral venous disease
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phlebitis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shock haemorrhagic
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Subgaleal haematoma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Temporal arteritis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis superficial
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (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
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose ulceration
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
Adverse event
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest pain
|
|
|
subjects affected / exposed
|
26 / 8028 (0.32%) |
22 / 8043 (0.27%) |
occurrences causally related to treatment / all
|
0 / 27 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Death
|
|
|
subjects affected / exposed
|
67 / 8028 (0.83%) |
67 / 8043 (0.83%) |
occurrences causally related to treatment / all
|
0 / 67 |
0 / 67 |
deaths causally related to treatment / all
|
0 / 67 |
0 / 67 |
Device battery issue
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device dislocation
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
7 / 8028 (0.09%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Accidental death
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
Asthenia
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
7 / 8043 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
Capsular contracture associated with breast implant
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest discomfort
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cyst
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device adhesion issue
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device breakage
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device damage
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device malfunction
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device material issue
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug intolerance
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug withdrawal syndrome
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial pain
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fatigue
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General symptom
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hernia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ill-defined disorder
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Impaired healing
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implant site reaction
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malaise
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device complication
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multi-organ disorder
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Multi-organ failure
|
|
|
subjects affected / exposed
|
6 / 8028 (0.07%) |
10 / 8043 (0.12%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 9 |
Nodule
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oral administration complication
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral swelling
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
subjects affected / exposed
|
7 / 8028 (0.09%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue inflammation
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Strangulated hernia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden death
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
15 / 8043 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 15 |
Systemic inflammatory response syndrome
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
Anaphylactic reaction
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaphylactic shock
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug hypersensitivity
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypersensitivity
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Social circumstances
|
|
|
Immobile
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (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
|
|
|
Endometrial atrophy
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
6 / 8028 (0.07%) |
12 / 8043 (0.15%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic floor muscle weakness
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine prolapse
|
|
|
subjects affected / exposed
|
15 / 8028 (0.19%) |
15 / 8043 (0.19%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adnexa uteri mass
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adnexal torsion
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anisomastia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast mass
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical dysplasia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical leukoplakia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical polyp
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colpocele
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystocele
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
7 / 8043 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysfunctional uterine bleeding
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial hyperplasia
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Genital prolapse
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metrorrhagia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic pain
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic prolapse
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectocele
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine polyp
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal fistula
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
10 / 8028 (0.12%) |
7 / 8043 (0.09%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulval leukoplakia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulvar dysplasia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulvovaginal pruritus
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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
|
|
|
Asthma
|
|
|
subjects affected / exposed
|
19 / 8028 (0.24%) |
10 / 8043 (0.12%) |
occurrences causally related to treatment / all
|
0 / 24 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
38 / 8028 (0.47%) |
36 / 8043 (0.45%) |
occurrences causally related to treatment / all
|
0 / 49 |
0 / 47 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 5 |
Nasal polyps
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal cyst
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
10 / 8028 (0.12%) |
13 / 8043 (0.16%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
28 / 8028 (0.35%) |
31 / 8043 (0.39%) |
occurrences causally related to treatment / all
|
0 / 31 |
0 / 32 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 7 |
Pulmonary hypertension
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary mass
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (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
|
7 / 8028 (0.09%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Respiratory distress
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Respiratory failure
|
|
|
subjects affected / exposed
|
10 / 8028 (0.12%) |
14 / 8043 (0.17%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 8 |
Acute pulmonary oedema
|
|
|
subjects affected / exposed
|
9 / 8028 (0.11%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 1 |
Acute respiratory distress syndrome
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Acute respiratory failure
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 3 |
Aspiration
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Asthmatic crisis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atelectasis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Bronchitis chronic
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cough
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
subjects affected / exposed
|
6 / 8028 (0.07%) |
6 / 8043 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Emphysema
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eosinophilic pneumonia chronic
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epiglottic cyst
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
6 / 8043 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemothorax
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrothorax
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Laryngeal granuloma
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal polyp
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung consolidation
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Mediastinal cyst
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal septum deviation
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive airways disorder
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Oesophagobronchial fistula
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal pouch
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pickwickian syndrome
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleurisy
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleuritic pain
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
6 / 8043 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
Pneumonitis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pneumothorax
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Pulmonary arteriopathy
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
4 / 8028 (0.05%) |
8 / 8043 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 4 |
Pulmonary ossification
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary thrombosis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
2 / 8028 (0.02%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Respiratory disorder
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract inflammation
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus polyp degeneration
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Throat irritation
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheal stenosis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vocal cord disorder
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vocal cord polyp
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Alcohol abuse
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol withdrawal syndrome
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety disorder
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety disorder due to a general medical condition
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bipolar disorder
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delirium
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Confusional state
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
10 / 8028 (0.12%) |
10 / 8043 (0.12%) |
occurrences causally related to treatment / all
|
1 / 10 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysthymic disorder
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysphemia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
3 / 8028 (0.04%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental disorder
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mood disorder due to a general medical condition
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Panic attack
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychogenic pain disorder
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychotic disorder
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicide attempt
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Blood pressure increased
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram QT prolonged
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram abnormal
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Grip strength decreased
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart rate irregular
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigation
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
4 / 8028 (0.05%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
Ankle fracture
|
|
|
subjects affected / exposed
|
21 / 8028 (0.26%) |
13 / 8043 (0.16%) |
occurrences causally related to treatment / all
|
0 / 25 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clavicle fracture
|
|
|
subjects affected / exposed
|
8 / 8028 (0.10%) |
6 / 8043 (0.07%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Contusion
|
|
|
subjects affected / exposed
|
16 / 8028 (0.20%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Femoral neck fracture
|
|
|
subjects affected / exposed
|
66 / 8028 (0.82%) |
36 / 8043 (0.45%) |
occurrences causally related to treatment / all
|
0 / 70 |
0 / 36 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
subjects affected / exposed
|
42 / 8028 (0.52%) |
46 / 8043 (0.57%) |
occurrences causally related to treatment / all
|
0 / 43 |
1 / 51 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
subjects affected / exposed
|
12 / 8028 (0.15%) |
11 / 8043 (0.14%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
subjects affected / exposed
|
11 / 8028 (0.14%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Forearm fracture
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fractured sacrum
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head injury
|
|
|
subjects affected / exposed
|
13 / 8028 (0.16%) |
9 / 8043 (0.11%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Heat stroke
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
subjects affected / exposed
|
114 / 8028 (1.42%) |
61 / 8043 (0.76%) |
occurrences causally related to treatment / all
|
0 / 115 |
0 / 62 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Humerus fracture
|
|
|
subjects affected / exposed
|
51 / 8028 (0.64%) |
30 / 8043 (0.37%) |
occurrences causally related to treatment / all
|
0 / 51 |
0 / 31 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iliotibial band syndrome
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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
|
7 / 8028 (0.09%) |
6 / 8043 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laceration
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
6 / 8043 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb injury
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
subjects affected / exposed
|
27 / 8028 (0.34%) |
16 / 8043 (0.20%) |
occurrences causally related to treatment / all
|
0 / 29 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Meniscus injury
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periprosthetic fracture
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pubis fracture
|
|
|
subjects affected / exposed
|
10 / 8028 (0.12%) |
11 / 8043 (0.14%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
subjects affected / exposed
|
81 / 8028 (1.01%) |
71 / 8043 (0.88%) |
occurrences causally related to treatment / all
|
0 / 83 |
0 / 73 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
subjects affected / exposed
|
6 / 8028 (0.07%) |
6 / 8043 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
subjects affected / exposed
|
28 / 8028 (0.35%) |
13 / 8043 (0.16%) |
occurrences causally related to treatment / all
|
0 / 33 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
subjects affected / exposed
|
23 / 8028 (0.29%) |
13 / 8043 (0.16%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulna fracture
|
|
|
subjects affected / exposed
|
28 / 8028 (0.35%) |
17 / 8043 (0.21%) |
occurrences causally related to treatment / all
|
0 / 28 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
subjects affected / exposed
|
7 / 8028 (0.09%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract stoma complication
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
7 / 8043 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wound dehiscence
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acetabulum fracture
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Animal bite
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic injury
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Arterial injury
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial restenosis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthropod bite
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back injury
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder injury
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone fissure
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac valve rupture
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical vertebral fracture
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chillblains
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Comminuted fracture
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Compression fracture
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Concussion
|
|
|
subjects affected / exposed
|
8 / 8028 (0.10%) |
6 / 8043 (0.07%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug dispensing error
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Face injury
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture displacement
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fractured ischium
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gun shot wound
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hand fracture
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heat exhaustion
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heat illness
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Jaw fracture
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint injury
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament rupture
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament sprain
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb crushing injury
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb traumatic amputation
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mouth injury
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple injuries
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Muscle injury
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle rupture
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle strain
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Patella fracture
|
|
|
subjects affected / exposed
|
11 / 8028 (0.14%) |
8 / 8043 (0.10%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perineal injury
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural complication
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Post procedural discomfort
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural fistula
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural inflammation
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural oedema
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post-traumatic neck syndrome
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative adhesion
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative hernia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural complication
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural nausea
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural pain
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary contusion
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
subjects affected / exposed
|
10 / 8028 (0.12%) |
7 / 8043 (0.09%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Road traffic accident
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Scapula fracture
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scar
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skull fractured base
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue injury
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal column injury
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Spinal compression fracture
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal cord injury cervical
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Splenic rupture
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sternal fracture
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Sternal injury
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous haematoma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural haemorrhage
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Synovial rupture
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon injury
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thermal burn
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic haemothorax
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic intracranial haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic shock
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulnar nerve injury
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular injury
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound haemorrhage
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
Atrial septal defect
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital bronchiectasis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital cystic kidney disease
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Exomphalos
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertrophic cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiac disorders
|
|
|
Acute myocardial infarction
|
|
|
subjects affected / exposed
|
59 / 8028 (0.73%) |
56 / 8043 (0.70%) |
occurrences causally related to treatment / all
|
0 / 64 |
2 / 58 |
deaths causally related to treatment / all
|
0 / 14 |
0 / 16 |
Angina pectoris
|
|
|
subjects affected / exposed
|
44 / 8028 (0.55%) |
40 / 8043 (0.50%) |
occurrences causally related to treatment / all
|
0 / 47 |
0 / 45 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
subjects affected / exposed
|
8 / 8028 (0.10%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Arrhythmia supraventricular
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
85 / 8028 (1.06%) |
76 / 8043 (0.94%) |
occurrences causally related to treatment / all
|
0 / 104 |
0 / 89 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
Atrial flutter
|
|
|
subjects affected / exposed
|
7 / 8028 (0.09%) |
8 / 8043 (0.10%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block complete
|
|
|
subjects affected / exposed
|
6 / 8028 (0.07%) |
6 / 8043 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
7 / 8028 (0.09%) |
10 / 8043 (0.12%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
subjects affected / exposed
|
13 / 8028 (0.16%) |
10 / 8043 (0.12%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 12 |
0 / 7 |
Cardiac disorder
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiac failure
|
|
|
subjects affected / exposed
|
44 / 8028 (0.55%) |
37 / 8043 (0.46%) |
occurrences causally related to treatment / all
|
0 / 47 |
0 / 40 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 9 |
Cardiac failure chronic
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
7 / 8043 (0.09%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiac failure congestive
|
|
|
subjects affected / exposed
|
36 / 8028 (0.45%) |
39 / 8043 (0.48%) |
occurrences causally related to treatment / all
|
2 / 38 |
0 / 40 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 8 |
Cardio-respiratory arrest
|
|
|
subjects affected / exposed
|
17 / 8028 (0.21%) |
11 / 8043 (0.14%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 14 |
0 / 11 |
Coronary artery disease
|
|
|
subjects affected / exposed
|
32 / 8028 (0.40%) |
32 / 8043 (0.40%) |
occurrences causally related to treatment / all
|
1 / 35 |
0 / 35 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hypertensive heart disease
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
subjects affected / exposed
|
49 / 8028 (0.61%) |
47 / 8043 (0.58%) |
occurrences causally related to treatment / all
|
0 / 52 |
0 / 50 |
deaths causally related to treatment / all
|
0 / 19 |
0 / 16 |
Myocardial ischaemia
|
|
|
subjects affected / exposed
|
15 / 8028 (0.19%) |
19 / 8043 (0.24%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Sinus node dysfunction
|
|
|
subjects affected / exposed
|
10 / 8028 (0.12%) |
10 / 8043 (0.12%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute left ventricular failure
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute coronary syndrome
|
|
|
subjects affected / exposed
|
9 / 8028 (0.11%) |
10 / 8043 (0.12%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adams-Stokes syndrome
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve disease
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
subjects affected / exposed
|
34 / 8028 (0.42%) |
34 / 8043 (0.42%) |
occurrences causally related to treatment / all
|
1 / 37 |
0 / 43 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve incompetence
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve stenosis
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial tachycardia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block first degree
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular dissociation
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block second degree
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bundle branch block bilateral
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradyarrhythmia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bundle branch block left
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (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 right
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure acute
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Cardiac tamponade
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiac valve disease
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiac ventricular thrombosis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiogenic shock
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 5 |
Cardiopulmonary failure
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Cardiovascular disorder
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiovascular insufficiency
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congestive cardiomyopathy
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cor pulmonale acute
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery insufficiency
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Coronary artery occlusion
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery perforation
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Coronary artery stenosis
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cytotoxic cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extrasystoles
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart valve incompetence
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Left ventricular failure
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Microvascular coronary artery disease
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve disease
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Mitral valve incompetence
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Mitral valve stenosis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocarditis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pericardial haemorrhage
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Postinfarction angina
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prinzmetal angina
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Right ventricular failure
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Sinoatrial block
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Stress cardiomyopathy
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular extrasystoles
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachyarrhythmia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachycardia paroxysmal
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular arrhythmia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ventricular dysfunction
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular extrasystoles
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular fibrillation
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular tachycardia
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
Carotid artery occlusion
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral arteriosclerosis
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
subjects affected / exposed
|
10 / 8028 (0.12%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 2 |
Cerebral infarction
|
|
|
subjects affected / exposed
|
19 / 8028 (0.24%) |
32 / 8043 (0.40%) |
occurrences causally related to treatment / all
|
0 / 19 |
2 / 33 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Cerebral ischaemia
|
|
|
subjects affected / exposed
|
9 / 8028 (0.11%) |
8 / 8043 (0.10%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
subjects affected / exposed
|
46 / 8028 (0.57%) |
72 / 8043 (0.90%) |
occurrences causally related to treatment / all
|
1 / 47 |
2 / 72 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 10 |
Cerebrovascular disorder
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular insufficiency
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Dizziness
|
|
|
subjects affected / exposed
|
8 / 8028 (0.10%) |
8 / 8043 (0.10%) |
occurrences causally related to treatment / all
|
0 / 8 |
3 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
6 / 8043 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Essential tremor
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiplegia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic cerebral infarction
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
subjects affected / exposed
|
41 / 8028 (0.51%) |
40 / 8043 (0.50%) |
occurrences causally related to treatment / all
|
0 / 42 |
0 / 42 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 4 |
Lacunar infarction
|
|
|
subjects affected / exposed
|
9 / 8028 (0.11%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelitis transverse
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parkinson's disease
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Radicular syndrome
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiculopathy
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sciatic nerve palsy
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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
|
20 / 8028 (0.25%) |
32 / 8043 (0.40%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 35 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Transient ischaemic attack
|
|
|
subjects affected / exposed
|
35 / 8028 (0.44%) |
34 / 8043 (0.42%) |
occurrences causally related to treatment / all
|
0 / 38 |
2 / 37 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular encephalopathy
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Altered state of consciousness
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Amyotrophic lateral sclerosis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Apallic syndrome
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aphasia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ataxia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal ganglia haemorrhage
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Basal ganglia infarction
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain injury
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Brain oedema
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain stem infarction
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain stem stroke
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid arteriosclerosis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery aneurysm
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery disease
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery thrombosis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid sinus syndrome
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
9 / 8043 (0.11%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar infarction
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral artery embolism
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral circulatory failure
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haematoma
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral thrombosis
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral venous thrombosis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical myelopathy
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical radiculopathy
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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
|
3 / 8028 (0.04%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Complex partial seizures
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cranial nerve disorder
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia Alzheimer's type
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Depressed level of consciousness
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic neuropathy
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysarthria
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyslalia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolic cerebral infarction
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Frontotemporal dementia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Haemorrhage intracranial
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Haemorrhagic stroke
|
|
|
subjects affected / exposed
|
6 / 8028 (0.07%) |
10 / 8043 (0.12%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 8 |
Headache
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
1 / 4 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic encephalopathy
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocephalus
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive encephalopathy
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertonia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic coma
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic unconsciousness
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotonia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
IIIrd nerve paralysis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracranial aneurysm
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Intracranial haematoma
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracranial venous sinus thrombosis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic neuropathy
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
subjects affected / exposed
|
8 / 8028 (0.10%) |
6 / 8043 (0.07%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar radiculopathy
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Memory impairment
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningorrhagia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Migraine
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Morton's neuralgia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myasthenia gravis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve compression
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuritis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (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
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraparesis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parkinsonism
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Partial seizures
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral nerve lesion
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral sensorimotor neuropathy
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyneuropathy
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post herpetic neuralgia
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Presyncope
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ruptured cerebral aneurysm
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Sciatica
|
|
|
subjects affected / exposed
|
6 / 8028 (0.07%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sedation
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seizure
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sensory disturbance
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Senile dementia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Slow speech
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Status epilepticus
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Thrombotic stroke
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Thalamus haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient global amnesia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Trigeminal neuralgia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VIIth nerve paralysis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral artery stenosis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular dementia
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebrobasilar insufficiency
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
White matter lesion
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
subjects affected / exposed
|
22 / 8028 (0.27%) |
16 / 8043 (0.20%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood disorder
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
5 / 8028 (0.06%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polycythaemia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia megaloblastic
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia vitamin B12 deficiency
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aplastic anaemia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Autoimmune haemolytic anaemia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coagulopathy
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Febrile neutropenia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic diathesis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic disorder
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypochromic anaemia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune thrombocytopenic purpura
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenitis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenopathy
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lymphadenopathy mediastinal
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Neutropenia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pernicious anaemia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
Deafness neurosensory
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden hearing loss
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
16 / 8043 (0.20%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
6 / 8043 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute vestibular syndrome
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
External ear disorder
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inner ear disorder
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniere's disease
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurosensory hypoacusis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otosclerosis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tinnitus
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tympanic membrane perforation
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Amaurosis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract
|
|
|
subjects affected / exposed
|
84 / 8028 (1.05%) |
99 / 8043 (1.23%) |
occurrences causally related to treatment / all
|
0 / 114 |
0 / 133 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract nuclear
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract subcapsular
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal tear
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal vein thrombosis
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Age-related macular degeneration
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angle closure glaucoma
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blindness
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blindness unilateral
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chalazion
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Choroiditis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ciliary body disorder
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Conjunctival haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Corneal opacity
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystoid macular oedema
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dacryostenosis acquired
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diplopia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Entropion
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Excessive eye blinking
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eyelid ptosis
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glaucoma
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
8 / 8043 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iritis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Keratitis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Keratitis interstitial
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Keratopathy
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lacrimal disorder
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lens disorder
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular degeneration
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular fibrosis
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular hole
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Maculopathy
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myopia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neovascular age-related macular degeneration
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Optic atrophy
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Optic ischaemic neuropathy
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Posterior capsule opacification
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal artery embolism
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal degeneration
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal dystrophy
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal vein occlusion
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinopathy
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Trichiasis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulcerative keratitis
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vision blurred
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual acuity reduced
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual impairment
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous haemorrhage
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Abdominal pain
|
|
|
subjects affected / exposed
|
11 / 8028 (0.14%) |
10 / 8043 (0.12%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal prolapse
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
subjects affected / exposed
|
7 / 8028 (0.09%) |
6 / 8043 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum
|
|
|
subjects affected / exposed
|
10 / 8028 (0.12%) |
9 / 8043 (0.11%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
9 / 8043 (0.11%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterovesical fistula
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Faecaloma
|
|
|
subjects affected / exposed
|
6 / 8028 (0.07%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric disorder
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
9 / 8028 (0.11%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Gastroduodenitis
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
subjects affected / exposed
|
10 / 8028 (0.12%) |
10 / 8043 (0.12%) |
occurrences causally related to treatment / all
|
0 / 10 |
1 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
subjects affected / exposed
|
8 / 8028 (0.10%) |
7 / 8043 (0.09%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Inguinal hernia
|
|
|
subjects affected / exposed
|
12 / 8028 (0.15%) |
8 / 8043 (0.10%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
subjects affected / exposed
|
11 / 8028 (0.14%) |
11 / 8043 (0.14%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Irritable bowel syndrome
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
subjects affected / exposed
|
6 / 8028 (0.07%) |
8 / 8043 (0.10%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Pancreatitis chronic
|
|
|
subjects affected / exposed
|
7 / 8028 (0.09%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
12 / 8028 (0.15%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 1 |
Abdominal adhesions
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal distension
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal hernia
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal hernia obstructive
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Abdominal pain lower
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
7 / 8043 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Anal fissure
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fistula
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal inflammation
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal stenosis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ascites
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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 / 8028 (0.00%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Change of bowel habit
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic gastritis
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
7 / 8043 (0.09%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
subjects affected / exposed
|
6 / 8028 (0.07%) |
8 / 8043 (0.10%) |
occurrences causally related to treatment / all
|
0 / 6 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis microscopic
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ulcerative
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Constipation
|
|
|
subjects affected / exposed
|
10 / 8028 (0.12%) |
9 / 8043 (0.11%) |
occurrences causally related to treatment / all
|
1 / 10 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Crohn's disease
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dental caries
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
8 / 8028 (0.10%) |
12 / 8043 (0.15%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticular perforation
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Diverticulitis intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum oesophageal
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dolichocolon acquired
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal perforation
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Duodenal ulcer
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer perforation
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Duodenitis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysbacteriosis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocele
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocutaneous fistula
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erosive oesophagitis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Faecal incontinence
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral hernia
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral hernia incarcerated
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Food poisoning
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Functional gastrointestinal disorder
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric antral vascular ectasia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric polyps
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer perforation
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
10 / 8028 (0.12%) |
19 / 8043 (0.24%) |
occurrences causally related to treatment / all
|
1 / 11 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorder
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
7 / 8028 (0.09%) |
6 / 8043 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Gastrointestinal inflammation
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal motility disorder
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal obstruction
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
subjects affected / exposed
|
10 / 8028 (0.12%) |
11 / 8043 (0.14%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoids thrombosed
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hernial eventration
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus paralytic
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Incarcerated umbilical hernia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal ischaemia
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal mass
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Intestinal polyp
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal prolapse
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intussusception
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischiorectal hernia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Large intestine polyp
|
|
|
subjects affected / exposed
|
10 / 8028 (0.12%) |
6 / 8043 (0.07%) |
occurrences causally related to treatment / all
|
1 / 10 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar hernia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mallory-Weiss syndrome
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mechanical ileus
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melaena
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric artery embolism
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mouth cyst
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mouth ulceration
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nausea
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstruction gastric
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal achalasia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal fistula
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal hypomotility
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal pain
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal stenosis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal varices haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis ulcerative
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oral pain
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic cyst
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic pseudocyst
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
6 / 8028 (0.07%) |
8 / 8043 (0.10%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pancreatitis necrotising
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Peptic ulcer
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer haemorrhage
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer perforation
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngo-oesophageal diverticulum
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
6 / 8043 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Rectal polyp
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal prolapse
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland calculus
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic artery aneurysm
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stomach mass
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subileus
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Toothache
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varices oesophageal
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Volvulus
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vomiting
|
|
|
subjects affected / exposed
|
6 / 8028 (0.07%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Bile duct stone
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
11 / 8043 (0.14%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary dilatation
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
subjects affected / exposed
|
15 / 8028 (0.19%) |
21 / 8043 (0.26%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
39 / 8028 (0.49%) |
34 / 8043 (0.42%) |
occurrences causally related to treatment / all
|
0 / 43 |
0 / 34 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cirrhosis
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bile duct obstruction
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct stenosis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary colic
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary fistula
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
3 / 8028 (0.04%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis acute
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
subjects affected / exposed
|
15 / 8028 (0.19%) |
7 / 8043 (0.09%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cholecystitis chronic
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic hepatitis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder disorder
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (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
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cyst
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic failure
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic steatosis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis cholestatic
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatorenal failure
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Jaundice
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaundice cholestatic
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Liver disorder
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-alcoholic steatohepatitis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Post cholecystectomy syndrome
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Decubitus ulcer
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Skin necrosis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subacute cutaneous lupus erythematosus
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Actinic keratosis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute generalised exanthematous pustulosis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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
|
4 / 8028 (0.05%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blister
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermal cyst
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis allergic
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis atopic
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis contact
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatomyositis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eczema
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erythema multiforme
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erythema nodosum
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hand dermatitis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Henoch-Schonlein purpura
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkeratosis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypersensitivity vasculitis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lentigo
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lichen sclerosus
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurodermatitis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pemphigoid
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pruritus generalised
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyoderma gangrenosum
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash erythematous
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash generalised
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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
|
6 / 8028 (0.07%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin wrinkling
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urticaria
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
Acute kidney injury
|
|
|
subjects affected / exposed
|
7 / 8028 (0.09%) |
7 / 8043 (0.09%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Bladder prolapse
|
|
|
subjects affected / exposed
|
7 / 8028 (0.09%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
11 / 8028 (0.14%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephropathy
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Renal artery stenosis
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric stenosis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute prerenal failure
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Azotaemia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bladder cyst
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder diverticulum
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder irritation
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder perforation
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus bladder
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus ureteric
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus urethral
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus urinary
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 3 |
Cystitis haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glomerulonephritis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Glomerulonephritis membranous
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glomerulonephritis rapidly progressive
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematuria
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertonic bladder
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oliguria
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pollakiuria
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal colic
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Renal impairment
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal mass
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal tubular disorder
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scleroderma renal crisis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress urinary incontinence
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tubulointerstitial nephritis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral caruncle
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral polyp
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary bladder polyp
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary incontinence
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
3 / 8043 (0.04%) |
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
|
4 / 8028 (0.05%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Goitre
|
|
|
subjects affected / exposed
|
7 / 8028 (0.09%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperparathyroidism
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperparathyroidism primary
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperthyroidism
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic nodular goitre
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal insufficiency
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Autoimmune thyroiditis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperadrenalism
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypothyroidism
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inappropriate antidiuretic hormone secretion
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Primary hypothyroidism
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Secondary hyperthyroidism
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid cyst
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroiditis subacute
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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
|
|
|
Arthralgia
|
|
|
subjects affected / exposed
|
8 / 8028 (0.10%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot deformity
|
|
|
subjects affected / exposed
|
10 / 8028 (0.12%) |
14 / 8043 (0.17%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture delayed union
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemarthrosis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
11 / 8028 (0.14%) |
14 / 8043 (0.17%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
subjects affected / exposed
|
8 / 8028 (0.10%) |
9 / 8043 (0.11%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
8 / 8043 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
subjects affected / exposed
|
123 / 8028 (1.53%) |
147 / 8043 (1.83%) |
occurrences causally related to treatment / all
|
0 / 141 |
0 / 167 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyarthritis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
subjects affected / exposed
|
12 / 8028 (0.15%) |
18 / 8043 (0.22%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
subjects affected / exposed
|
8 / 8028 (0.10%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic lupus erythematosus
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis
|
|
|
subjects affected / exposed
|
8 / 8028 (0.10%) |
12 / 8043 (0.15%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atlantoaxial instability
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Axillary mass
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back pain
|
|
|
subjects affected / exposed
|
22 / 8028 (0.27%) |
20 / 8043 (0.25%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone loss
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone pain
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondrocalcinosis pyrophosphate
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondropathy
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Connective tissue disorder
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dupuytren's contracture
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eosinophilic fasciitis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facet joint syndrome
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture malunion
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture pain
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc degeneration
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc disorder
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc space narrowing
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaw cyst
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint adhesion
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint range of motion decreased
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint stiffness
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint swelling
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Knee deformity
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Monarthritis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Morphoea
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle spasms
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myalgia
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nodal osteoarthritis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteochondritis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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 / 8028 (0.02%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteosclerosis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
1 / 8028 (0.01%) |
9 / 8043 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periarthritis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periostitis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plantar fasciitis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
5 / 8028 (0.06%) |
6 / 8043 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rheumatoid arthritis
|
|
|
subjects affected / exposed
|
7 / 8028 (0.09%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scleroderma
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scoliosis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue necrosis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
17 / 8028 (0.21%) |
15 / 8043 (0.19%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal pain
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylitis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondyloarthropathy
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Synovial cyst
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
6 / 8043 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Synovitis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendonitis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Trigger finger
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulnocarpal abutment syndrome
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
|
|
Appendiceal abscess
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
subjects affected / exposed
|
13 / 8028 (0.16%) |
20 / 8043 (0.25%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
subjects affected / exposed
|
16 / 8028 (0.20%) |
16 / 8043 (0.20%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchopneumonia
|
|
|
subjects affected / exposed
|
17 / 8028 (0.21%) |
19 / 8043 (0.24%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 7 |
Cellulitis
|
|
|
subjects affected / exposed
|
16 / 8028 (0.20%) |
17 / 8043 (0.21%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
29 / 8028 (0.36%) |
35 / 8043 (0.44%) |
occurrences causally related to treatment / all
|
0 / 31 |
0 / 35 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gastroenteritis Escherichia coli
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal viral infection
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective exacerbation of chronic obstructive airways disease
|
|
|
subjects affected / exposed
|
8 / 8028 (0.10%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Localised infection
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
11 / 8028 (0.14%) |
15 / 8043 (0.19%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Peritonitis
|
|
|
subjects affected / exposed
|
6 / 8028 (0.07%) |
8 / 8043 (0.10%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 4 |
Pneumonia
|
|
|
subjects affected / exposed
|
128 / 8028 (1.59%) |
119 / 8043 (1.48%) |
occurrences causally related to treatment / all
|
0 / 133 |
0 / 138 |
deaths causally related to treatment / all
|
0 / 24 |
0 / 23 |
Pulmonary sepsis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
8 / 8028 (0.10%) |
6 / 8043 (0.07%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sepsis
|
|
|
subjects affected / exposed
|
19 / 8028 (0.24%) |
23 / 8043 (0.29%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 10 |
0 / 14 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
54 / 8028 (0.67%) |
54 / 8043 (0.67%) |
occurrences causally related to treatment / all
|
1 / 64 |
1 / 58 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Wound infection
|
|
|
subjects affected / exposed
|
8 / 8028 (0.10%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal abscess
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal sepsis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Abdominal wall abscess
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess neck
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute sinusitis
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Amoebic colitis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis perforated
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis infective
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Beta haemolytic streptococcal infection
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchiolitis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Burn infection
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Campylobacter infection
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carbuncle
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter site infection
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Central nervous system viral infection
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chlamydial infection
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis infective
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic sinusitis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile infection
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cutaneous tuberculosis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis
|
|
|
subjects affected / exposed
|
8 / 8028 (0.10%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dacryocystitis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dengue fever
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related infection
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related sepsis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gangrene
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea infectious
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
subjects affected / exposed
|
20 / 8028 (0.25%) |
25 / 8043 (0.31%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 27 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Dysentery
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endophthalmitis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis infectious
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterobacter pneumonia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Erysipelas
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
6 / 8043 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erythema migrans
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder empyema
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gangrene
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gastritis viral
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis bacterial
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis clostridial
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis rotavirus
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal infection
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Graft infection
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin abscess
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma infection
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Helicobacter gastritis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Helicobacter infection
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis A
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis E
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes simplex encephalitis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Herpes zoster infection neurological
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected bites
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected dermal cyst
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected varicose vein
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective exacerbation of bronchiectasis
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Influenza
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal fistula infection
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Keratitis bacterial
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Labyrinthitis
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngitis
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver abscess
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lobar pneumonia
|
|
|
subjects affected / exposed
|
12 / 8028 (0.15%) |
11 / 8043 (0.14%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
Lower respiratory tract infection bacterial
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung infection
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malaria
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mediastinitis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Meningitis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis bacterial
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurosyphilis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenic sepsis
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal candidiasis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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
|
1 / 8028 (0.01%) |
0 / 8043 (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
|
3 / 8028 (0.04%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic abscess
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parotitis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic sepsis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periorbital cellulitis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonsillar abscess
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonsillitis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngitis
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngotonsillitis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia bacterial
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pneumonia necrotising
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pneumonia pneumococcal
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia viral
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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
|
2 / 8028 (0.02%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
subjects affected / exposed
|
5 / 8028 (0.06%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudomembranous colitis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudomonal bacteraemia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary echinococciasis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary tuberculosis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelocystitis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis chronic
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyometra
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyonephrosis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal abscess
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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 infection
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salmonellosis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Septic shock
|
|
|
subjects affected / exposed
|
7 / 8028 (0.09%) |
12 / 8043 (0.15%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 10 |
Sialoadenitis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinusitis
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinobronchitis
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin infection
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal bacteraemia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal skin infection
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stoma site abscess
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous abscess
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdiaphragmatic abscess
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tick-borne fever
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsillitis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Tooth infection
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheitis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection bacterial
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection pseudomonal
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
subjects affected / exposed
|
4 / 8028 (0.05%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Vaginal abscess
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular neuronitis
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral infection
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral labyrinthitis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection staphylococcal
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound sepsis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metabolism and nutrition disorders
|
|
|
Dehydration
|
|
|
subjects affected / exposed
|
7 / 8028 (0.09%) |
14 / 8043 (0.17%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Folate deficiency
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (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
|
7 / 8028 (0.09%) |
10 / 8043 (0.12%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
16 / 8028 (0.20%) |
9 / 8043 (0.11%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cachexia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decreased appetite
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
subjects affected / exposed
|
10 / 8028 (0.12%) |
5 / 8043 (0.06%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Diabetes mellitus inadequate control
|
|
|
subjects affected / exposed
|
9 / 8028 (0.11%) |
8 / 8043 (0.10%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
4 / 8043 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrolyte imbalance
|
|
|
subjects affected / exposed
|
2 / 8028 (0.02%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gout
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperosmolar state
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
3 / 8043 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hypophagia
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ketoacidosis
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (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
|
1 / 8028 (0.01%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metabolic acidosis
|
|
|
subjects affected / exposed
|
0 / 8028 (0.00%) |
1 / 8043 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic disorder
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Type 1 diabetes mellitus
|
|
|
subjects affected / exposed
|
1 / 8028 (0.01%) |
0 / 8043 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
subjects affected / exposed
|
3 / 8028 (0.04%) |
2 / 8043 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |