Serious adverse events
|
Ivabradine |
Placebo |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
3379 / 9539 (35.42%) |
3263 / 9544 (34.19%) |
number of deaths (all causes)
|
363 |
356 |
number of deaths resulting from adverse events
|
1 |
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Acute leukaemia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Acute myeloid leukaemia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma gastric
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Adenocarcinoma of colon
|
|
|
subjects affected / exposed
|
8 / 9539 (0.08%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma pancreas
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenolymphoma
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal adenoma
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenosquamous cell lung cancer
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Anal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angiofibroma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Astrocytoma, low grade
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
B precursor type acute leukaemia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Basal cell carcinoma
|
|
|
subjects affected / exposed
|
24 / 9539 (0.25%) |
21 / 9544 (0.22%) |
occurrences causally related to treatment / all
|
0 / 25 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basosquamous carcinoma
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basosquamous carcinoma of skin
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign breast neoplasm
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of prostate
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign pleural neoplasm
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign renal neoplasm
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
9 / 9544 (0.09%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer recurrent
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer stage I, with cancer in situ
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer stage II
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neoplasm
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder papilloma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma recurrent
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma stage II
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma stage III
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bowen's disease
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain neoplasm
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Brain neoplasm malignant
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Brain stem glioma
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Breast cancer
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer metastatic
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Breast cancer recurrent
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer stage I
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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 II
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchial carcinoma
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchioloalveolar carcinoma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cancer pain
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid body tumour
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Castleman's disease
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral hygroma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervix carcinoma
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cervix carcinoma stage III
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangiocarcinoma
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cholesteatoma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic lymphocytic leukaemia
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic lymphocytic leukaemia stage 2
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clear cell renal cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clear cell sarcoma of soft tissue
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon adenoma
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer metastatic
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Colon cancer stage 0
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal cancer
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal cancer metastatic
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diffuse large B-cell lymphoma
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diffuse large B-cell lymphoma stage III
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diffuse large B-cell lymphoma stage IV
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear neoplasm malignant
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ependymoma
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extranodal marginal zone B-cell lymphoma (MALT type)
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder cancer
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder neoplasm
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric adenoma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric cancer
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Gastric cancer stage IV
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal carcinoma
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal tract adenoma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrooesophageal cancer
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Haemangioma of bone
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cancer
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Hepatic cancer metastatic
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Hepatocellular carcinoma
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hodgkin's disease
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive ductal breast carcinoma
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large cell lung cancer
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large cell lung cancer metastatic
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Large cell lung cancer stage II
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine benign neoplasm
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal cancer
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Laryngeal cancer recurrent
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Laryngeal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Lentigo maligna
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lip and/or oral cavity cancer
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Lip and/or oral cavity cancer stage IV
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lipoma
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma metastatic
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 6 |
Lung adenocarcinoma stage IV
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung cancer metastatic
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
10 / 9544 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 6 |
Lung carcinoma cell type unspecified stage II
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung carcinoma cell type unspecified stage IV
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lung neoplasm
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Lung neoplasm malignant
|
|
|
subjects affected / exposed
|
7 / 9539 (0.07%) |
12 / 9544 (0.13%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 5 |
Lung squamous cell carcinoma metastatic
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Lung squamous cell carcinoma stage III
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphangiosis carcinomatosa
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Malignant ascites
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant glioma
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Malignant melanoma
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant neoplasm of ampulla of Vater
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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 choroid
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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 eyelid
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant oligodendroglioma
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Malignant pleural effusion
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningioma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesothelioma
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to abdominal cavity
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastases to adrenals
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastases to bone
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Metastases to bone marrow
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastases to central nervous system
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Metastases to eye
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to liver
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Metastases to lung
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastases to lymph nodes
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastases to peritoneum
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastases to the mediastinum
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to spine
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastatic bronchial carcinoma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Metastatic carcinoma of the bladder
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
3 / 9539 (0.03%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Metastatic malignant melanoma
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastatic neoplasm
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic renal cell carcinoma
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Metastatic pain
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastatic uterine cancer
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Myelodysplastic syndrome
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelofibrosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myeloproliferative disorder
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasopharyngeal cancer
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Neoplasm
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm skin
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroendocrine carcinoma metastatic
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroendocrine tumour
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nodular melanoma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Non-small cell lung cancer
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Non-small cell lung cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-small cell lung cancer stage IIIA
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal adenocarcinoma metastatic
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal carcinoma
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Oesophageal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Oropharyngeal cancer
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian adenoma
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cancer
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ovarian cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian epithelial cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian germ cell teratoma benign
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic carcinoma
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pancreatic carcinoma metastatic
|
|
|
subjects affected / exposed
|
7 / 9539 (0.07%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 3 |
Pancreatic neoplasm
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Papillary tumour of renal pelvis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Penis carcinoma stage II
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pharyngeal cancer recurrent
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pineal parenchymal neoplasm malignant
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pituitary tumour benign
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pituitary tumour recurrent
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasma cell leukaemia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Plasma cell myeloma
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Pleural mesothelioma
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural neoplasm
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polycythaemia vera
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
subjects affected / exposed
|
38 / 9539 (0.40%) |
18 / 9544 (0.19%) |
occurrences causally related to treatment / all
|
0 / 38 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer metastatic
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Prostate cancer recurrent
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer stage I
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer stage II
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer stage III
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer stage IV
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic adenoma
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal cancer
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Rectal cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Rectal cancer recurrent
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal cancer stage 0
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal cancer stage IV
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Rectosigmoid cancer
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal neoplasm
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Renal cancer metastatic
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cancer stage I
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal oncocytoma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhabdomyosarcoma
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland adenoma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland cancer
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin cancer
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small cell lung cancer
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Small cell lung cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Small intestine carcinoma
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal meningioma benign
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Squamous cell carcinoma
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Squamous cell carcinoma of head and neck
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of lung
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Squamous cell carcinoma of pharynx
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of skin
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the cervix
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Squamous cell carcinoma of the hypopharynx
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the oral cavity
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Testicular cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Throat cancer
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid neoplasm
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tongue neoplasm malignant stage unspecified
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Tonsil cancer
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Transitional cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulval cancer
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Aortic aneurysm
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic aneurysm rupture
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Aortic arteriosclerosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic dilatation
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic dissection
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic occlusion
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic thrombosis
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial rupture
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial stenosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure fluctuation
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure inadequately controlled
|
|
|
subjects affected / exposed
|
7 / 9539 (0.07%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
19 / 9539 (0.20%) |
17 / 9544 (0.18%) |
occurrences causally related to treatment / all
|
0 / 19 |
1 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Diabetic macroangiopathy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic microangiopathy
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic vascular disorder
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Essential hypertension
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extremity necrosis
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral artery aneurysm
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral artery dissection
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral artery embolism
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral artery occlusion
|
|
|
subjects affected / exposed
|
10 / 9539 (0.10%) |
14 / 9544 (0.15%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertension
|
|
|
subjects affected / exposed
|
204 / 9539 (2.14%) |
144 / 9544 (1.51%) |
occurrences causally related to treatment / all
|
2 / 220 |
0 / 152 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
subjects affected / exposed
|
104 / 9539 (1.09%) |
105 / 9544 (1.10%) |
occurrences causally related to treatment / all
|
1 / 117 |
0 / 119 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
subjects affected / exposed
|
13 / 9539 (0.14%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
1 / 15 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotension
|
|
|
subjects affected / exposed
|
25 / 9539 (0.26%) |
36 / 9544 (0.38%) |
occurrences causally related to treatment / all
|
5 / 26 |
0 / 37 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemic shock
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Iliac artery occlusion
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iliac artery rupture
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intermittent claudication
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jugular vein thrombosis
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Labile blood pressure
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Labile hypertension
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leriche syndrome
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphoedema
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphostasis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant hypertension
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
subjects affected / exposed
|
12 / 9539 (0.13%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
2 / 12 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pallor
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
subjects affected / exposed
|
52 / 9539 (0.55%) |
67 / 9544 (0.70%) |
occurrences causally related to treatment / all
|
0 / 58 |
0 / 70 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery aneurysm
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery dissection
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
subjects affected / exposed
|
13 / 9539 (0.14%) |
12 / 9544 (0.13%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral embolism
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
5 / 9539 (0.05%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Peripheral vascular disorder
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phlebitis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phlebitis superficial
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shock haemorrhagic
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Subclavian artery occlusion
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian artery stenosis
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian steal syndrome
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subgaleal haematoma
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systolic hypertension
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis superficial
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose ulceration
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose vein
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vasculitis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vasculitis necrotising
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vena cava thrombosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous insufficiency
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis limb
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Withdrawal hypertension
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
Abdominal hernia repair
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol detoxification
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic aneurysm repair
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic bypass
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve repair
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve replacement
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial bypass operation
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial stent insertion
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula operation
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neoplasm surgery
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blepharoplasty
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bunion operation
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac ablation
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac aneurysm repair
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac rehabilitation therapy
|
|
|
subjects affected / exposed
|
23 / 9539 (0.24%) |
19 / 9544 (0.20%) |
occurrences causally related to treatment / all
|
0 / 30 |
0 / 27 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid angioplasty
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery bypass
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery stent insertion
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid endarterectomy
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract operation
|
|
|
subjects affected / exposed
|
9 / 9539 (0.09%) |
9 / 9544 (0.09%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chemotherapy
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystectomy
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholesteatoma removal
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Circumcision
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary angioplasty
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary arterial stent insertion
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery bypass
|
|
|
subjects affected / exposed
|
10 / 9539 (0.10%) |
18 / 9544 (0.19%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary revascularisation
|
|
|
subjects affected / exposed
|
8 / 9539 (0.08%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus management
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dupuytren's contracture operation
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fasciectomy
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral hernia repair
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Finger amputation
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrectomy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric banding
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric bypass
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glaucoma surgery
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip arthroplasty
|
|
|
subjects affected / exposed
|
9 / 9539 (0.09%) |
9 / 9544 (0.09%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hospitalisation
|
|
|
subjects affected / exposed
|
8 / 9539 (0.08%) |
10 / 9544 (0.10%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocele operation
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileostomy closure
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implantable defibrillator insertion
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incisional hernia repair
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infusion
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia repair
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
9 / 9544 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Internal fixation of fracture
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraocular lens extraction
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Keratoplasty
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Knee arthroplasty
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
12 / 9544 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Knee operation
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leg amputation
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lens extraction
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device removal
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver operation
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniscus removal
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metatarsal excision
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve repair
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal polypectomy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obesity surgery
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal septal operation
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oophorectomy bilateral
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Percutaneous coronary intervention
|
|
|
subjects affected / exposed
|
15 / 9539 (0.16%) |
16 / 9544 (0.17%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Peripheral artery angioplasty
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery bypass
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery stent insertion
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Physiotherapy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radical hysterectomy
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiotherapy
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rehabilitation therapy
|
|
|
subjects affected / exposed
|
8 / 9539 (0.08%) |
10 / 9544 (0.10%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Removal of internal fixation
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery ablation
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal stone removal
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal laser coagulation
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rotator cuff repair
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shoulder arthroplasty
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus operation
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin neoplasm excision
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal operation
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suture insertion
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroidectomy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toe amputation
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transurethral prostatectomy
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia repair
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral dilation procedure
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary calculus removal
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine polypectomy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal prolapse repair
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
Apparent death
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthenia
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
2 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac death
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Chest discomfort
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest pain
|
|
|
subjects affected / exposed
|
32 / 9539 (0.34%) |
36 / 9544 (0.38%) |
occurrences causally related to treatment / all
|
0 / 35 |
0 / 50 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chills
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Death
|
|
|
subjects affected / exposed
|
10 / 9539 (0.10%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 10 |
0 / 7 |
Device breakage
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device dislocation
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device extrusion
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device failure
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device malfunction
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device occlusion
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Discomfort
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drowning
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Drug interaction
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Exercise tolerance decreased
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Face oedema
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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
|
7 / 9539 (0.07%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
2 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Feeling abnormal
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Feeling cold
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foreign body reaction
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised oedema
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hernia obstructive
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inflammation
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Irritability
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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
|
2 / 9539 (0.02%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device complication
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multi-organ failure
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 3 |
Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
38 / 9539 (0.40%) |
29 / 9544 (0.30%) |
occurrences causally related to treatment / all
|
0 / 43 |
1 / 31 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
subjects affected / exposed
|
9 / 9539 (0.09%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pacemaker generated arrhythmia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Puncture site haemorrhage
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal pain
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stent-graft endoleak
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden cardiac death
|
|
|
subjects affected / exposed
|
43 / 9539 (0.45%) |
46 / 9544 (0.48%) |
occurrences causally related to treatment / all
|
0 / 43 |
0 / 46 |
deaths causally related to treatment / all
|
0 / 43 |
0 / 46 |
Sudden death
|
|
|
subjects affected / exposed
|
75 / 9539 (0.79%) |
74 / 9544 (0.78%) |
occurrences causally related to treatment / all
|
0 / 75 |
0 / 74 |
deaths causally related to treatment / all
|
0 / 75 |
0 / 74 |
Systemic inflammatory response syndrome
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis in device
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Immune system disorders
|
|
|
Allergy to arthropod sting
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Amyloidosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaphylactic reaction
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaphylactic shock
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Drug hypersensitivity
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Food allergy
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypersensitivity
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Social circumstances
|
|
|
Activities of daily living impaired
|
|
|
subjects affected / exposed
|
11 / 9539 (0.12%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
11 / 11 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol use
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immobile
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired driving ability
|
|
|
subjects affected / exposed
|
15 / 9539 (0.16%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
15 / 15 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Acquired hydrocele
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acquired phimosis
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign prostatic hyperplasia
|
|
|
subjects affected / exposed
|
23 / 9539 (0.24%) |
28 / 9544 (0.29%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast disorder
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystocele
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epididymitis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Female genital tract fistula
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Genital prolapse
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gynaecomastia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic adhesions
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatomegaly
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine prolapse
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterovaginal prolapse
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicocele
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulval disorder
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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
|
|
|
Acquired tracheo-oesophageal fistula
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute pulmonary oedema
|
|
|
subjects affected / exposed
|
31 / 9539 (0.32%) |
30 / 9544 (0.31%) |
occurrences causally related to treatment / all
|
0 / 33 |
0 / 32 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 4 |
Acute respiratory distress syndrome
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Acute respiratory failure
|
|
|
subjects affected / exposed
|
13 / 9539 (0.14%) |
12 / 9544 (0.13%) |
occurrences causally related to treatment / all
|
1 / 13 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Alveolitis allergic
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asphyxia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Asthma
|
|
|
subjects affected / exposed
|
21 / 9539 (0.22%) |
16 / 9544 (0.17%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aspiration
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atelectasis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis chronic
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchopneumopathy
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Choking
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
64 / 9539 (0.67%) |
52 / 9544 (0.54%) |
occurrences causally related to treatment / all
|
0 / 84 |
0 / 62 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Chronic respiratory failure
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cough
|
|
|
subjects affected / exposed
|
7 / 9539 (0.07%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cyanosis central
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diaphragmatic paralysis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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
|
23 / 9539 (0.24%) |
23 / 9544 (0.24%) |
occurrences causally related to treatment / all
|
0 / 25 |
2 / 26 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Dyspnoea at rest
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea exertional
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Emphysema
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Granulomatous pneumonitis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemothorax
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydropneumothorax
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hydrothorax
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Idiopathic pulmonary fibrosis
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Laryngeal stenosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung consolidation
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung cyst
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung infiltration
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal polyps
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal septum deviation
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Organising pneumonia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal oedema
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pickwickian syndrome
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
8 / 9539 (0.08%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural fibrosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural haemorrhage
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pleurisy
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
subjects affected / exposed
|
7 / 9539 (0.07%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pneumonitis
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary arterial hypertension
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary artery thrombosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary congestion
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
15 / 9539 (0.16%) |
24 / 9544 (0.25%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 8 |
Pulmonary fibrosis
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pulmonary granuloma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary hypertension
|
|
|
subjects affected / exposed
|
19 / 9539 (0.20%) |
10 / 9544 (0.10%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Pulmonary mass
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary microemboli
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pulmonary oedema
|
|
|
subjects affected / exposed
|
15 / 9539 (0.16%) |
12 / 9544 (0.13%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pulmonary thrombosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Reflux laryngitis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiration abnormal
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory acidosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory arrest
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Respiratory disorder
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory distress
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
subjects affected / exposed
|
21 / 9539 (0.22%) |
27 / 9544 (0.28%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 6 |
Sinus polyp
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sleep apnoea syndrome
|
|
|
subjects affected / exposed
|
7 / 9539 (0.07%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Snoring
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Status asthmaticus
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachypnoea
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vocal cord polyp
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wheezing
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Acute psychosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Aggression
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Agitated depression
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Agitation
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol abuse
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol withdrawal syndrome
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcoholism
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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
|
4 / 9539 (0.04%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bipolar I disorder
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bipolar disorder
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 4 |
Confusional state
|
|
|
subjects affected / exposed
|
7 / 9539 (0.07%) |
10 / 9544 (0.10%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delirium
|
|
|
subjects affected / exposed
|
8 / 9539 (0.08%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delirium tremens
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delusional disorder, unspecified type
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depressed mood
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
57 / 9539 (0.60%) |
54 / 9544 (0.57%) |
occurrences causally related to treatment / all
|
0 / 59 |
0 / 54 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression suicidal
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depressive symptom
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Disorientation
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysthymic disorder
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hallucination
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hallucination, auditory
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hallucination, visual
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hallucinations, mixed
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impulsive behaviour
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Insomnia
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intentional drug misuse
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mood disorder due to a general medical condition
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervousness
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obsessive thoughts
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Panic attack
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paranoia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Persecutory delusion
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychomotor retardation
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychosomatic disease
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychotic disorder due to a general medical condition
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychotic disorder
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Sleep disorder
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sleep terror
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicidal ideation
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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 / 9539 (0.01%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Acute hepatic failure
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Alcoholic liver disease
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct stone
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Biliary cirrhosis primary
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary colic
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary tract disorder
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
2 / 9539 (0.02%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
subjects affected / exposed
|
9 / 9539 (0.09%) |
10 / 9544 (0.10%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis acute
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
subjects affected / exposed
|
19 / 9539 (0.20%) |
17 / 9544 (0.18%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis chronic
|
|
|
subjects affected / exposed
|
7 / 9539 (0.07%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
12 / 9539 (0.13%) |
20 / 9544 (0.21%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cholestasis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic hepatitis
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cirrhosis alcoholic
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug-induced liver injury
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder perforation
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder polyp
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cirrhosis
|
|
|
subjects affected / exposed
|
7 / 9539 (0.07%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatic congestion
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cyst
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic failure
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatic mass
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic steatosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis acute
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis alcoholic
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis cholestatic
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatomegaly
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperbilirubinaemia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic hepatitis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaundice
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (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 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver disorder
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver injury
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Portal vein thrombosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sphincter of Oddi dysfunction
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post cholecystectomy syndrome
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Alanine aminotransferase increased
|
|
|
subjects affected / exposed
|
11 / 9539 (0.12%) |
11 / 9544 (0.12%) |
occurrences causally related to treatment / all
|
0 / 11 |
1 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Amylase increased
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriogram carotid
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriogram coronary
|
|
|
subjects affected / exposed
|
43 / 9539 (0.45%) |
53 / 9544 (0.56%) |
occurrences causally related to treatment / all
|
0 / 45 |
0 / 58 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthroscopy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aspartate aminotransferase increased
|
|
|
subjects affected / exposed
|
12 / 9539 (0.13%) |
10 / 9544 (0.10%) |
occurrences causally related to treatment / all
|
0 / 12 |
1 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Biopsy prostate
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood alkaline phosphatase increased
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatine phosphokinase increased
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood glucose decreased
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood glucose increased
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood iron decreased
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood lactate dehydrogenase increased
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood parathyroid hormone decreased
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood potassium decreased
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood potassium increased
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure decreased
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure increased
|
|
|
subjects affected / exposed
|
24 / 9539 (0.25%) |
13 / 9544 (0.14%) |
occurrences causally related to treatment / all
|
0 / 26 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure systolic decreased
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure systolic increased
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood triglycerides increased
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Body temperature increased
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
C-reactive protein increased
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac enzymes increased
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carbohydrate antigen 19-9 increased
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac stress test abnormal
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiovascular evaluation
|
|
|
subjects affected / exposed
|
78 / 9539 (0.82%) |
84 / 9544 (0.88%) |
occurrences causally related to treatment / all
|
0 / 98 |
0 / 100 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheterisation cardiac
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystoscopy normal
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest X-ray abnormal
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ECG signs of myocardial ischaemia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ejection fraction decreased
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram QT prolonged
|
|
|
subjects affected / exposed
|
57 / 9539 (0.60%) |
18 / 9544 (0.19%) |
occurrences causally related to treatment / all
|
42 / 60 |
6 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram ST segment depression
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram ST segment elevation
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram T wave inversion
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram ambulatory
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram change
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram repolarisation abnormality
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibrin D dimer increased
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gamma-glutamyltransferase increased
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal examination
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoglobin decreased
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart rate decreased
|
|
|
subjects affected / exposed
|
55 / 9539 (0.58%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
40 / 55 |
4 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
International normalised ratio increased
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraocular pressure increased
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
7 / 9539 (0.07%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oxygen saturation decreased
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Platelet count decreased
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary arterial pressure increased
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Red blood cell sedimentation rate increased
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Romberg test positive
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sleep study
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcus test positive
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress echocardiogram abnormal
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid function test abnormal
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Treponema test positive
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Troponin increased
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Weight decreased
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
11 / 9544 (0.12%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
White blood cell count increased
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
Abdominal injury
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wound dehiscence
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Accident
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Accident at home
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Accidental overdose
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Agitation postoperative
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol poisoning
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia postoperative
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic injury
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial restenosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthropod sting
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asbestosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blindness traumatic
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone fissure
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain contusion
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Burns second degree
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carbon monoxide poisoning
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiac contusion
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac procedure complication
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac valve replacement complication
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac valve rupture
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery restenosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest injury
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clavicle fracture
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Concussion
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Contusion
|
|
|
subjects affected / exposed
|
9 / 9539 (0.09%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery restenosis
|
|
|
subjects affected / exposed
|
9 / 9539 (0.09%) |
12 / 9544 (0.13%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Corrosive gastritis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Crushing injury of trunk
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extradural haematoma
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye contusion
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye injury
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Face injury
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Febrile nonhaemolytic transfusion reaction
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
subjects affected / exposed
|
95 / 9539 (1.00%) |
109 / 9544 (1.14%) |
occurrences causally related to treatment / all
|
4 / 96 |
2 / 109 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
subjects affected / exposed
|
13 / 9539 (0.14%) |
12 / 9544 (0.13%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
subjects affected / exposed
|
15 / 9539 (0.16%) |
10 / 9544 (0.10%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foreign body
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Forearm fracture
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foreign body in eye
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hand fracture
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head injury
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
10 / 9544 (0.10%) |
occurrences causally related to treatment / all
|
1 / 4 |
2 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heat stroke
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ilium fracture
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intentional overdose
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc injury
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal anastomosis complication
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaw fracture
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint dislocation postoperative
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
1 / 9539 (0.01%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kidney rupture
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laceration
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament rupture
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament sprain
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb crushing injury
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb injury
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb traumatic amputation
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lip injury
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Meniscus injury
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple fractures
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple injuries
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Muscle rupture
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neck injury
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoradionecrosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic injury
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Penetrating abdominal trauma
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periorbital haematoma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery restenosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumoconiosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax traumatic
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural contusion
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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
|
2 / 9539 (0.02%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Post procedural fistula
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematuria
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural hypothyroidism
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Post procedural myocardial infarction
|
|
|
subjects affected / exposed
|
14 / 9539 (0.15%) |
13 / 9544 (0.14%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Post procedural pulmonary embolism
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post-thoracotomy pain syndrome
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post-traumatic pain
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative thoracic procedure complication
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative ileus
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound complication
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural hypertension
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural hypotension
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural pain
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural site reaction
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pubis fracture
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiation oesophagitis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
subjects affected / exposed
|
8 / 9539 (0.08%) |
15 / 9544 (0.16%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal haematoma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
subjects affected / exposed
|
23 / 9539 (0.24%) |
26 / 9544 (0.27%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Rib fracture
|
|
|
subjects affected / exposed
|
8 / 9539 (0.08%) |
15 / 9544 (0.16%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seroma
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shunt thrombosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Silicosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skull fracture
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skull fractured base
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal column injury
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic rupture
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stab wound
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous haematoma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
subjects affected / exposed
|
8 / 9539 (0.08%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Suture related complication
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon injury
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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
|
1 / 9539 (0.01%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tongue injury
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transfusion reaction
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic haematoma
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic intracranial haemorrhage
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Traumatic ulcer
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulna fracture
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft complication
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft occlusion
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft thrombosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vasoplegia syndrome
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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
|
4 / 9539 (0.04%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound complication
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound necrosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
Adenomatous polyposis coli
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital umbilical hernia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Factor V Leiden mutation
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic myopathy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyloric stenosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Accelerated idioventricular rhythm
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute coronary syndrome
|
|
|
subjects affected / exposed
|
17 / 9539 (0.18%) |
21 / 9544 (0.22%) |
occurrences causally related to treatment / all
|
1 / 18 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 1 |
Acute left ventricular failure
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Acute myocardial infarction
|
|
|
subjects affected / exposed
|
200 / 9539 (2.10%) |
208 / 9544 (2.18%) |
occurrences causally related to treatment / all
|
2 / 216 |
0 / 229 |
deaths causally related to treatment / all
|
0 / 23 |
0 / 23 |
Adams-Stokes syndrome
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
subjects affected / exposed
|
294 / 9539 (3.08%) |
330 / 9544 (3.46%) |
occurrences causally related to treatment / all
|
3 / 314 |
2 / 361 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Angina unstable
|
|
|
subjects affected / exposed
|
409 / 9539 (4.29%) |
433 / 9544 (4.54%) |
occurrences causally related to treatment / all
|
4 / 479 |
0 / 524 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Aortic valve disease
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve disease mixed
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve incompetence
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve sclerosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Aortic valve stenosis
|
|
|
subjects affected / exposed
|
12 / 9539 (0.13%) |
9 / 9544 (0.09%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia supraventricular
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriospasm coronary
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
subjects affected / exposed
|
49 / 9539 (0.51%) |
41 / 9544 (0.43%) |
occurrences causally related to treatment / all
|
0 / 52 |
0 / 45 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
336 / 9539 (3.52%) |
232 / 9544 (2.43%) |
occurrences causally related to treatment / all
|
22 / 381 |
2 / 262 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial tachycardia
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block complete
|
|
|
subjects affected / exposed
|
17 / 9539 (0.18%) |
13 / 9544 (0.14%) |
occurrences causally related to treatment / all
|
4 / 17 |
1 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block first degree
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
2 / 4 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block second degree
|
|
|
subjects affected / exposed
|
22 / 9539 (0.23%) |
13 / 9544 (0.14%) |
occurrences causally related to treatment / all
|
10 / 22 |
7 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular dissociation
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
101 / 9539 (1.06%) |
21 / 9544 (0.22%) |
occurrences causally related to treatment / all
|
91 / 102 |
15 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bundle branch block
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bundle branch block left
|
|
|
subjects affected / exposed
|
7 / 9539 (0.07%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac aneurysm
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
9 / 9544 (0.09%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
subjects affected / exposed
|
15 / 9539 (0.16%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Cardiac asthma
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiac failure
|
|
|
subjects affected / exposed
|
357 / 9539 (3.74%) |
346 / 9544 (3.63%) |
occurrences causally related to treatment / all
|
13 / 415 |
2 / 394 |
deaths causally related to treatment / all
|
0 / 16 |
0 / 14 |
Cardiac failure acute
|
|
|
subjects affected / exposed
|
37 / 9539 (0.39%) |
23 / 9544 (0.24%) |
occurrences causally related to treatment / all
|
0 / 45 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 9 |
Cardiac failure congestive
|
|
|
subjects affected / exposed
|
31 / 9539 (0.32%) |
24 / 9544 (0.25%) |
occurrences causally related to treatment / all
|
0 / 33 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Cardiac failure chronic
|
|
|
subjects affected / exposed
|
25 / 9539 (0.26%) |
29 / 9544 (0.30%) |
occurrences causally related to treatment / all
|
1 / 28 |
0 / 36 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Cardiac tamponade
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiogenic shock
|
|
|
subjects affected / exposed
|
30 / 9539 (0.31%) |
22 / 9544 (0.23%) |
occurrences causally related to treatment / all
|
0 / 30 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 12 |
0 / 9 |
Cardiomegaly
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiopulmonary failure
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiovascular insufficiency
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Congestive cardiomyopathy
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cor pulmonale
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Coronary artery disease
|
|
|
subjects affected / exposed
|
20 / 9539 (0.21%) |
25 / 9544 (0.26%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cor pulmonale chronic
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery dissection
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery insufficiency
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery occlusion
|
|
|
subjects affected / exposed
|
14 / 9539 (0.15%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
subjects affected / exposed
|
18 / 9539 (0.19%) |
26 / 9544 (0.27%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery thrombosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dressler's syndrome
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis noninfective
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart valve incompetence
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive heart disease
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracardiac thrombus
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
9 / 9544 (0.09%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic cardiomyopathy
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left atrial dilatation
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left ventricular dysfunction
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left ventricular failure
|
|
|
subjects affected / exposed
|
9 / 9539 (0.09%) |
10 / 9544 (0.10%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Left ventricular hypertrophy
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Low cardiac output syndrome
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
subjects affected / exposed
|
16 / 9539 (0.17%) |
14 / 9544 (0.15%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve prolapse
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial depression
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial fibrosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Myocardial infarction
|
|
|
subjects affected / exposed
|
98 / 9539 (1.03%) |
83 / 9544 (0.87%) |
occurrences causally related to treatment / all
|
0 / 104 |
0 / 88 |
deaths causally related to treatment / all
|
0 / 15 |
0 / 14 |
Myocardial ischaemia
|
|
|
subjects affected / exposed
|
23 / 9539 (0.24%) |
27 / 9544 (0.28%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 27 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Myocarditis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nodal arrhythmia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nodal rhythm
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Palpitations
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postinfarction angina
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prinzmetal angina
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhythm idioventricular
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Right ventricular failure
|
|
|
subjects affected / exposed
|
8 / 9539 (0.08%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Sick sinus syndrome
|
|
|
subjects affected / exposed
|
9 / 9539 (0.09%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
4 / 9 |
4 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Silent myocardial infarction
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinoatrial block
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus arrest
|
|
|
subjects affected / exposed
|
9 / 9539 (0.09%) |
9 / 9544 (0.09%) |
occurrences causally related to treatment / all
|
8 / 9 |
4 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus arrhythmia
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
subjects affected / exposed
|
48 / 9539 (0.50%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
42 / 49 |
4 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus tachycardia
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
12 / 9544 (0.13%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular extrasystoles
|
|
|
subjects affected / exposed
|
8 / 9539 (0.08%) |
15 / 9544 (0.16%) |
occurrences causally related to treatment / all
|
1 / 8 |
2 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
17 / 9539 (0.18%) |
21 / 9544 (0.22%) |
occurrences causally related to treatment / all
|
1 / 18 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachyarrhythmia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachyarrhythmia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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
|
2 / 9539 (0.02%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Torsade de pointes
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tricuspid valve incompetence
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Trifascicular block
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular arrhythmia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ventricular extrasystoles
|
|
|
subjects affected / exposed
|
32 / 9539 (0.34%) |
21 / 9544 (0.22%) |
occurrences causally related to treatment / all
|
2 / 32 |
2 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular failure
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ventricular fibrillation
|
|
|
subjects affected / exposed
|
20 / 9539 (0.21%) |
20 / 9544 (0.21%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 6 |
Ventricular tachycardia
|
|
|
subjects affected / exposed
|
35 / 9539 (0.37%) |
21 / 9544 (0.22%) |
occurrences causally related to treatment / all
|
3 / 39 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Wolff-Parkinson-White syndrome
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
Amnesia
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Altered state of consciousness
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Amyotrophic lateral sclerosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anticholinergic syndrome
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aphasia
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ataxia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Autonomic neuropathy
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Balance disorder
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain hypoxia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain injury
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain oedema
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain stem infarction
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid aneurysm rupture
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
4 / 9539 (0.04%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery aneurysm
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery disease
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery dissection
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery occlusion
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
subjects affected / exposed
|
51 / 9539 (0.53%) |
43 / 9544 (0.45%) |
occurrences causally related to treatment / all
|
0 / 57 |
0 / 45 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid sinus syndrome
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar atrophy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cerebellar ischaemia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar syndrome
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral arteriosclerosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral artery stenosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral atrophy
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haematoma
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Cerebral infarction
|
|
|
subjects affected / exposed
|
15 / 9539 (0.16%) |
13 / 9544 (0.14%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Cerebral ischaemia
|
|
|
subjects affected / exposed
|
8 / 9539 (0.08%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral microangiopathy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
subjects affected / exposed
|
31 / 9539 (0.32%) |
40 / 9544 (0.42%) |
occurrences causally related to treatment / all
|
0 / 32 |
0 / 44 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 5 |
Cerebrovascular disorder
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular insufficiency
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical cord compression
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervicobrachial syndrome
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cognitive disorder
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coma
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Convulsion
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Coordination abnormal
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cranial nerve disorder
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cranial nerve paralysis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cubital tunnel syndrome
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia Alzheimer's type
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia of the Alzheimer's type, with delusions
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Demyelinating polyneuropathy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depressed level of consciousness
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic hyperglycaemic coma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Diabetic neuropathy
|
|
|
subjects affected / exposed
|
10 / 9539 (0.10%) |
10 / 9544 (0.10%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness
|
|
|
subjects affected / exposed
|
19 / 9539 (0.20%) |
18 / 9544 (0.19%) |
occurrences causally related to treatment / all
|
3 / 19 |
3 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness postural
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drop attacks
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysarthria
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dystonic tremor
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalitis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalomyelitis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
subjects affected / exposed
|
7 / 9539 (0.07%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Essential tremor
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extrapyramidal disorder
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial nerve disorder
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Grand mal convulsion
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial paresis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Guillain-Barre syndrome
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic stroke
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
12 / 9544 (0.13%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 5 |
Headache
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemianopia homonymous
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Horner's syndrome
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocephalus
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive encephalopathy
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoaesthesia
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
9 / 9544 (0.09%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic coma
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypoglycaemic unconsciousness
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
9 / 9544 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyporeflexia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxic-ischaemic encephalopathy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intercostal neuralgia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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
|
4 / 9539 (0.04%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracranial hypotension
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracranial pressure increased
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic cerebral infarction
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic neuropathy
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
subjects affected / exposed
|
97 / 9539 (1.02%) |
90 / 9544 (0.94%) |
occurrences causally related to treatment / all
|
1 / 100 |
0 / 95 |
deaths causally related to treatment / all
|
0 / 13 |
0 / 6 |
Lacunar infarction
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lethargy
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
32 / 9539 (0.34%) |
22 / 9544 (0.23%) |
occurrences causally related to treatment / all
|
3 / 32 |
1 / 22 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar radiculopathy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
4 / 9544 (0.04%) |
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
|
4 / 9539 (0.04%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Migraine
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Monoplegia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Movement disorder
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple sclerosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myasthenia gravis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelitis transverse
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelopathy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve compression
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve root compression
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve root lesion
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuralgia
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuritis cranial
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurodegenerative disorder
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurological decompensation
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normal pressure hydrocephalus
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraesthesia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraplegia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parkinson's disease
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parkinsonism
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Partial seizures
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral sensorimotor neuropathy
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral sensory neuropathy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyneuropathy
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Petit mal epilepsy
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Poor quality sleep
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post-injection delirium sedation syndrome
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post-traumatic headache
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Presyncope
|
|
|
subjects affected / exposed
|
15 / 9539 (0.16%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
4 / 15 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Posterior reversible encephalopathy syndrome
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychomotor hyperactivity
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyramidal tract syndrome
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radial nerve compression
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radicular pain
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radicular syndrome
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiculopathy
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Restless legs syndrome
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retrograde amnesia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sciatica
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Senile dementia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Speech disorder
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Somnolence
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal cord compression
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal vascular disorder
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylitic myelopathy
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Subdural hygroma
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Syncope
|
|
|
subjects affected / exposed
|
91 / 9539 (0.95%) |
89 / 9544 (0.93%) |
occurrences causally related to treatment / all
|
23 / 102 |
6 / 96 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thalamic infarction
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thalamus haemorrhage
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Thrombotic stroke
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonic convulsion
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tremor
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
subjects affected / exposed
|
56 / 9539 (0.59%) |
50 / 9544 (0.52%) |
occurrences causally related to treatment / all
|
3 / 59 |
0 / 50 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulnar neurapraxia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulnar tunnel syndrome
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VIIth nerve paralysis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VIth nerve disorder
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VIth nerve paralysis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular dementia
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular encephalopathy
|
|
|
subjects affected / exposed
|
11 / 9539 (0.12%) |
9 / 9544 (0.09%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral artery occlusion
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral artery stenosis
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebrobasilar insufficiency
|
|
|
subjects affected / exposed
|
15 / 9539 (0.16%) |
12 / 9544 (0.13%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo CNS origin
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vocal cord paresis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wernicke-Korsakoff syndrome
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Agranulocytosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia
|
|
|
subjects affected / exposed
|
30 / 9539 (0.31%) |
45 / 9544 (0.47%) |
occurrences causally related to treatment / all
|
0 / 30 |
0 / 45 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia folate deficiency
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia megaloblastic
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia vitamin B12 deficiency
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone marrow failure
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deficiency anaemia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Disseminated intravascular coagulation
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Febrile neutropenia
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Haemorrhagic diathesis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic anaemia
|
|
|
subjects affected / exposed
|
14 / 9539 (0.15%) |
15 / 9544 (0.16%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic disorder
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heparin-induced thrombocytopenia
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypochromic anaemia
|
|
|
subjects affected / exposed
|
8 / 9539 (0.08%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoprothrombinaemia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Idiopathic thrombocytopenic purpura
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iron deficiency anaemia
|
|
|
subjects affected / exposed
|
7 / 9539 (0.07%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukopenia
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenopathy
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenopathy mediastinal
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphopenia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Microcytic anaemia
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrogenic anaemia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normochromic normocytic anaemia
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Platelet dysfunction
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sideroblastic anaemia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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
|
15 / 9539 (0.16%) |
12 / 9544 (0.13%) |
occurrences causally related to treatment / all
|
0 / 17 |
1 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytopenic purpura
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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
|
|
|
Acute vestibular syndrome
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deafness neurosensory
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deafness unilateral
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematotympanum
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hearing impaired
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoacusis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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 / 9539 (0.00%) |
2 / 9544 (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 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden hearing loss
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tinnitus
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tympanic membrane disorder
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo
|
|
|
subjects affected / exposed
|
9 / 9539 (0.09%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
2 / 9 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular ataxia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular disorder
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Age-related macular degeneration
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Amaurosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
2 / 9539 (0.02%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angle closure glaucoma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blindness
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract
|
|
|
subjects affected / exposed
|
39 / 9539 (0.41%) |
32 / 9544 (0.34%) |
occurrences causally related to treatment / all
|
0 / 43 |
0 / 32 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blindness unilateral
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract diabetic
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract nuclear
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract subcapsular
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Choroidal effusion
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Choroidal neovascularisation
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dacryoadenitis acquired
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dacryostenosis acquired
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic glaucoma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic retinal oedema
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic retinopathy
|
|
|
subjects affected / exposed
|
9 / 9539 (0.09%) |
18 / 9544 (0.19%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diplopia
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glaucoma
|
|
|
subjects affected / exposed
|
20 / 9539 (0.21%) |
19 / 9544 (0.20%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glaucomatous optic disc atrophy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Keratitis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular degeneration
|
|
|
subjects affected / exposed
|
7 / 9539 (0.07%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular fibrosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular oedema
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normal tension glaucoma
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ocular hypertension
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ocular icterus
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Open angle glaucoma
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Optic atrophy
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ophthalmoplegia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papilloedema
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periorbital oedema
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Photophobia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pterygium
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Photopsia
|
|
|
subjects affected / exposed
|
28 / 9539 (0.29%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
29 / 31 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal aneurysm
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal artery occlusion
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal artery thrombosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal haemorrhage
|
|
|
subjects affected / exposed
|
10 / 9539 (0.10%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal tear
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal vascular thrombosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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 / 9539 (0.01%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal vein thrombosis
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinopathy haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinopathy hypertensive
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinoschisis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vision blurred
|
|
|
subjects affected / exposed
|
13 / 9539 (0.14%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
11 / 14 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual acuity reduced
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual impairment
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
2 / 3 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous detachment
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous floaters
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous haemorrhage
|
|
|
subjects affected / exposed
|
8 / 9539 (0.08%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Abdominal adhesions
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal discomfort
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal distension
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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 / 9539 (0.02%) |
2 / 9544 (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
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal rigidity
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal strangulated hernia
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acquired oesophageal web
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute abdomen
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fissure
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fistula
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal polyp
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal ulcer
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ascites
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Barrett's oesophagus
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Colitis ulcerative
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colonic pseudo-obstruction
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colonic stenosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Constipation
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Crohn's disease
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dental alveolar anomaly
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gastroparesis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diaphragmatic hernia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
subjects affected / exposed
|
10 / 9539 (0.10%) |
9 / 9544 (0.09%) |
occurrences causally related to treatment / all
|
1 / 10 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticular perforation
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dry mouth
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal obstruction
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Duodenal polyp
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
7 / 9539 (0.07%) |
11 / 9544 (0.12%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer perforation
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenitis haemorrhagic
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenitis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epigastric discomfort
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erosive duodenitis
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erosive oesophagitis
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Faecal incontinence
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Flatulence
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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
|
3 / 9539 (0.03%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Functional gastrointestinal disorder
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
0 / 9539 (0.00%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gastric mucosa erythema
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric polyps
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
subjects affected / exposed
|
8 / 9539 (0.08%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
subjects affected / exposed
|
10 / 9539 (0.10%) |
15 / 9544 (0.16%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer perforation
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gastric varices
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric varices haemorrhage
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
14 / 9539 (0.15%) |
13 / 9544 (0.14%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis atrophic
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
subjects affected / exposed
|
10 / 9539 (0.10%) |
10 / 9544 (0.10%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis haemorrhagic
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroduodenal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroduodenitis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroduodenitis haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal angiodysplasia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal angiodysplasia haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal dysplasia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal erosion
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
13 / 9539 (0.14%) |
11 / 9544 (0.12%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Gastrooesophageal reflux disease
|
|
|
subjects affected / exposed
|
12 / 9539 (0.13%) |
9 / 9544 (0.09%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrooesophagitis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematochezia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic erosive gastritis
|
|
|
subjects affected / exposed
|
7 / 9539 (0.07%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hernial eventration
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
subjects affected / exposed
|
7 / 9539 (0.07%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileal stenosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ileus paralytic
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired gastric emptying
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
subjects affected / exposed
|
29 / 9539 (0.30%) |
18 / 9544 (0.19%) |
occurrences causally related to treatment / all
|
0 / 31 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia strangulated
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia, obstructive
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal angina
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal fistula
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal ischaemia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal mass
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal polyp
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal polyp haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Irritable bowel syndrome
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
subjects affected / exposed
|
11 / 9539 (0.12%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukoplakia oral
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lip swelling
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mallory-Weiss syndrome
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mechanical ileus
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melaena
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric artery thrombosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Mesenteric haemorrhage
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric occlusion
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mikulicz's disease
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
12 / 9539 (0.13%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedematous pancreatitis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal achalasia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal stenosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal varices haemorrhage
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis haemorrhagic
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis ulcerative
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oral submucosal fibrosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic pseudocyst
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
subjects affected / exposed
|
9 / 9539 (0.09%) |
17 / 9544 (0.18%) |
occurrences causally related to treatment / all
|
1 / 9 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pancreatitis chronic
|
|
|
subjects affected / exposed
|
11 / 9539 (0.12%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periproctitis
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Proctitis ulcerative
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
5 / 9539 (0.05%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal polyp
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal prolapse
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reflux gastritis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retching
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland calculus
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sigmoiditis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal perforation
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic artery aneurysm
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subileus
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Swollen tongue
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis mesenteric vessel
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Tongue ulceration
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia, obstructive
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
8 / 9539 (0.08%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varices oesophageal
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Volvulus
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vomiting
|
|
|
subjects affected / exposed
|
9 / 9539 (0.09%) |
11 / 9544 (0.12%) |
occurrences causally related to treatment / all
|
1 / 9 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Angioedema
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
3 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cold sweat
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decubitus ulcer
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis allergic
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis bullous
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatomyositis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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 / 9539 (0.04%) |
9 / 9544 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dry gangrene
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ecchymosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eczema
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erythema
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hidradenitis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperhidrosis
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Keloid scar
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukocytoclastic vasculitis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lichen planus
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrobiosis lipoidica diabeticorum
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathic ulcer
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Panniculitis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parapsoriasis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pruritus
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pemphigus
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pruritus allergic
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psoriasis
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Purpura
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin lesion
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin necrosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
10 / 9544 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin ulcer haemorrhage
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Swelling face
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic skin eruption
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urticaria
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
Acute prerenal failure
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anuria
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder dilatation
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neck sclerosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder prolapse
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder perforation
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder stenosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder tamponade
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus bladder
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus ureteric
|
|
|
subjects affected / exposed
|
7 / 9539 (0.07%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus urethral
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
10 / 9539 (0.10%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis glandularis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis haemorrhagic
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis noninfective
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic nephropathy
|
|
|
subjects affected / exposed
|
11 / 9539 (0.12%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysuria
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glomerulonephritis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematuria
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydroureter
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive nephropathy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertonic bladder
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
IgA nephropathy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incontinence
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephroangiosclerosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
7 / 9539 (0.07%) |
14 / 9544 (0.15%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephropathy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephropathy toxic
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrotic syndrome
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive uropathy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pollakiuria
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prerenal failure
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery occlusion
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery stenosis
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery thrombosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
3 / 9539 (0.03%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cyst
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure
|
|
|
subjects affected / exposed
|
38 / 9539 (0.40%) |
30 / 9544 (0.31%) |
occurrences causally related to treatment / all
|
1 / 39 |
0 / 30 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
Renal failure acute
|
|
|
subjects affected / exposed
|
29 / 9539 (0.30%) |
35 / 9544 (0.37%) |
occurrences causally related to treatment / all
|
0 / 31 |
0 / 38 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Renal failure chronic
|
|
|
subjects affected / exposed
|
34 / 9539 (0.36%) |
17 / 9544 (0.18%) |
occurrences causally related to treatment / all
|
1 / 35 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Renal impairment
|
|
|
subjects affected / exposed
|
13 / 9539 (0.14%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal infarct
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal ischaemia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal tubular acidosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tubulointerstitial nephritis
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric obstruction
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric stenosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral disorder
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral obstruction
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary bladder haemorrhage
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary bladder polyp
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary incontinence
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
subjects affected / exposed
|
12 / 9539 (0.13%) |
18 / 9544 (0.19%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vesicoureteric reflux
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Autoimmune thyroiditis
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal insufficiency
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basedow's disease
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cushing's syndrome
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Empty sella syndrome
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Goitre
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperthyroidism
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypothyroidism
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inappropriate antidiuretic hormone secretion
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic nodular goitre
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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
|
|
|
Amyotrophy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ankylosing spondylitis
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthralgia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back pain
|
|
|
subjects affected / exposed
|
7 / 9539 (0.07%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CREST syndrome
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical spinal stenosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondrocalcinosis pyrophosphate
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondromalacia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Costochondritis
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dupuytren's contracture
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Exostosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Exostosis of jaw
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fasciitis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fistula
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot deformity
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gouty arthritis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gouty tophus
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin pain
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemarthrosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc compression
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc degeneration
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc disorder
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc displacement
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
12 / 9539 (0.13%) |
20 / 9544 (0.21%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kyphosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
subjects affected / exposed
|
9 / 9539 (0.09%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mobility decreased
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle haemorrhage
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle tightness
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
11 / 9544 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal stiffness
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myopathy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myopathy toxic
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neck pain
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathic arthropathy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteitis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
subjects affected / exposed
|
46 / 9539 (0.48%) |
43 / 9544 (0.45%) |
occurrences causally related to treatment / all
|
0 / 47 |
0 / 48 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteochondritis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteochondrosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoporosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoporosis postmenopausal
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoporotic fracture
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Patellofemoral pain syndrome
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periarthritis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polymyalgia rheumatica
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudarthrosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psoriatic arthropathy
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rheumatoid arthritis
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scoliosis
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal column stenosis
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
10 / 9544 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
subjects affected / exposed
|
18 / 9539 (0.19%) |
16 / 9544 (0.17%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondyloarthropathy
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sympathetic posterior cervical syndrome
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Synovitis
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic sclerosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tenosynovitis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral foraminal stenosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Abdominal wall abscess
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess jaw
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute hepatitis C
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute sinusitis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal candidiasis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendiceal abscess
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
subjects affected / exposed
|
16 / 9539 (0.17%) |
9 / 9544 (0.09%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis perforated
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerotic gangrene
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous graft site infection
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atypical pneumonia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial diarrhoea
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial infection
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial prostatitis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial sepsis
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Biliary tract infection
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Borrelia infection
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain abscess
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
subjects affected / exposed
|
16 / 9539 (0.17%) |
22 / 9544 (0.23%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchopneumonia
|
|
|
subjects affected / exposed
|
29 / 9539 (0.30%) |
24 / 9544 (0.25%) |
occurrences causally related to treatment / all
|
0 / 33 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Bronchitis bacterial
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchopulmonary aspergillosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Campylobacter gastroenteritis
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Candida pneumonia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Candidiasis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
subjects affected / exposed
|
23 / 9539 (0.24%) |
18 / 9544 (0.19%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis gangrenous
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervicitis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis suppurative
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis infective
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic hepatitis C
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic sinusitis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cystitis klebsiella
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dengue fever
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related infection
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot infection
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gangrene
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
13 / 9544 (0.14%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea infectious
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear infection
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Echinococciasis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Emphysematous cholecystitis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Empyema
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis bacterial
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Endocarditis enterococcal
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis staphylococcal
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Enterobacter sepsis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterococcal sepsis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis bacterial
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis infectious
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epiglottitis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
subjects affected / exposed
|
20 / 9539 (0.21%) |
15 / 9544 (0.16%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia infection
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
2 / 9539 (0.02%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Folliculitis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gangrene
|
|
|
subjects affected / exposed
|
7 / 9539 (0.07%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
16 / 9539 (0.17%) |
16 / 9544 (0.17%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis bacterial
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis clostridial
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis salmonella
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis shigella
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal bacterial infection
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal viral infection
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin abscess
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemophilus infection
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Helicobacter infection
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis A
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis B
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis C
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster infection neurological
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster ophthalmic
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster oticus
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected cyst
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected dermal cyst
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected skin ulcer
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infectious pleural effusion
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective exacerbation of bronchiectasis
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective exacerbation of chronic obstructive airways disease
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective myositis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injection site abscess
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral discitis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint abscess
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Keratitis herpetic
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngitis
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngitis bacterial
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngitis fungal
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Legionella infection
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver abscess
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lobar pneumonia
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
13 / 9544 (0.14%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Localised infection
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
9 / 9544 (0.09%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower respiratory tract infection bacterial
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung abscess
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung infection
|
|
|
subjects affected / exposed
|
11 / 9539 (0.12%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lyme disease
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphangitis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malaria
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mastoiditis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mediastinal abscess
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mediastinitis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis tuberculous
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis viral
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle abscess
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrotising fasciitis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal candidiasis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orchitis
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
11 / 9544 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis bacterial
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis chronic
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis media
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis media acute
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis media chronic
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic abscess
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perihepatic abscess
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perineal abscess
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periodontitis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal abscess
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
subjects affected / exposed
|
9 / 9539 (0.09%) |
9 / 9544 (0.09%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Peritonitis bacterial
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonsillar abscess
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pertussis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumococcal sepsis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
subjects affected / exposed
|
122 / 9539 (1.28%) |
102 / 9544 (1.07%) |
occurrences causally related to treatment / all
|
0 / 129 |
0 / 112 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 3 |
Pneumonia bacterial
|
|
|
subjects affected / exposed
|
7 / 9539 (0.07%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pneumonia escherichia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia haemophilus
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia klebsiella
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia moraxella
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia mycoplasmal
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia pneumococcal
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia pseudomonas aeruginosa
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia streptococcal
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia viral
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural cellulitis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural infection
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Post procedural sepsis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative abscess
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
12 / 9544 (0.13%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudomembranous colitis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudomonal bacteraemia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary sepsis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary tuberculoma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary tuberculosis
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Puncture site abscess
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Puncture site infection
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
8 / 9544 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis chronic
|
|
|
subjects affected / exposed
|
7 / 9539 (0.07%) |
6 / 9544 (0.06%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyoderma
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyonephrosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal tuberculosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory moniliasis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
subjects affected / exposed
|
5 / 9539 (0.05%) |
12 / 9544 (0.13%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection bacterial
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection viral
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salmonellosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sepsis
|
|
|
subjects affected / exposed
|
11 / 9539 (0.12%) |
11 / 9544 (0.12%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 3 |
Scrotal abscess
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Septic arthritis staphylococcal
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
9 / 9539 (0.09%) |
13 / 9544 (0.14%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 5 |
Sinusitis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin infection
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestine gangrene
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Sputum purulent
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal infection
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal osteomyelitis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (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
|
2 / 9539 (0.02%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Streptococcal sepsis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous abscess
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic candida
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsillitis bacterial
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth infection
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic shock syndrome
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheobronchitis
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tuberculosis gastrointestinal
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tuberculous pleurisy
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tubo-ovarian abscess
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Typhoid fever
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
subjects affected / exposed
|
6 / 9539 (0.06%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
26 / 9539 (0.27%) |
17 / 9544 (0.18%) |
occurrences causally related to treatment / all
|
0 / 26 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection bacterial
|
|
|
subjects affected / exposed
|
7 / 9539 (0.07%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection enterococcal
|
|
|
subjects affected / exposed
|
2 / 9539 (0.02%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
13 / 9544 (0.14%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Viral infection
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral pericarditis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection bacterial
|
|
|
subjects affected / exposed
|
3 / 9539 (0.03%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection pseudomonas
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Acidosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cachexia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decreased appetite
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dehydration
|
|
|
subjects affected / exposed
|
19 / 9539 (0.20%) |
19 / 9544 (0.20%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
subjects affected / exposed
|
59 / 9539 (0.62%) |
82 / 9544 (0.86%) |
occurrences causally related to treatment / all
|
0 / 65 |
0 / 87 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Diabetes mellitus inadequate control
|
|
|
subjects affected / exposed
|
34 / 9539 (0.36%) |
50 / 9544 (0.52%) |
occurrences causally related to treatment / all
|
0 / 36 |
0 / 53 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic complication
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fluid retention
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gout
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
3 / 9544 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypercholesterolaemia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
10 / 9539 (0.10%) |
4 / 9544 (0.04%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
subjects affected / exposed
|
13 / 9539 (0.14%) |
10 / 9544 (0.10%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertriglyceridaemia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypocalcaemia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
19 / 9539 (0.20%) |
12 / 9544 (0.13%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
4 / 9539 (0.04%) |
5 / 9544 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypomagnesaemia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
7 / 9544 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoproteinaemia
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Insulin-requiring type 2 diabetes mellitus
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ketoacidosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lactic acidosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic acidosis
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic alkalosis
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
2 / 9544 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obesity
|
|
|
subjects affected / exposed
|
0 / 9539 (0.00%) |
1 / 9544 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 1 diabetes mellitus
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (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
|
25 / 9539 (0.26%) |
47 / 9544 (0.49%) |
occurrences causally related to treatment / all
|
0 / 26 |
0 / 52 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 3 diabetes mellitus
|
|
|
subjects affected / exposed
|
1 / 9539 (0.01%) |
0 / 9544 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |