Serious adverse events
|
Evolocumab |
Placebo |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
3410 / 13769 (24.77%) |
3404 / 13756 (24.75%) |
number of deaths (all causes)
|
0 |
0 |
number of deaths resulting from adverse events
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Acute leukaemia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute myeloid leukaemia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma gastric
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma of appendix
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
subjects affected / exposed
|
17 / 13769 (0.12%) |
12 / 13756 (0.09%) |
occurrences causally related to treatment / all
|
0 / 17 |
1 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma pancreas
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal adenoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal gland cancer
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal neoplasm
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal cancer stage III
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal neoplasm
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anogenital warts
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
B-cell lymphoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
B-cell lymphoma stage I
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
B-cell prolymphocytic leukaemia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
11 / 13756 (0.08%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basosquamous carcinoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign gastric neoplasm
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign gastrointestinal neoplasm
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign lung neoplasm
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of adrenal gland
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of bladder
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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 prostate
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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 spinal cord
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign pancreatic neoplasm
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign renal neoplasm
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct cancer
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary adenoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder adenocarcinoma stage III
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder adenocarcinoma stage unspecified
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
subjects affected / exposed
|
12 / 13769 (0.09%) |
8 / 13756 (0.06%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer recurrent
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer stage 0, with cancer in situ
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer stage I, with cancer in situ
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer stage III
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neoplasm
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder papilloma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
subjects affected / exposed
|
9 / 13769 (0.07%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma recurrent
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma stage I
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (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
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma stage III
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma stage IV
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bowen's disease
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain neoplasm malignant
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer female
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer in situ
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer recurrent
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchial carcinoma
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchial neoplasm
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Burkitt's lymphoma
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carcinoid tumour pulmonary
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangiocarcinoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholesteatoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Choroid melanoma
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic lymphocytic leukaemia
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic myeloid leukaemia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
3 / 13769 (0.02%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon adenoma
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
subjects affected / exposed
|
11 / 13769 (0.08%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer stage I
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer stage III
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon neoplasm
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatofibrosarcoma protuberans
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ductal adenocarcinoma of pancreas
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial adenocarcinoma
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial adenoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fallopian tube cancer
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibroma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Follicular thyroid cancer
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder neoplasm
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric cancer
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric cancer stage 0
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric cancer stage IV
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal carcinoma
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal neoplasm
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
0 / 13769 (0.00%) |
1 / 13756 (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 / 13769 (0.01%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glioblastoma multiforme
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemangiopericytoma
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cancer
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic neoplasm
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatocellular carcinoma
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hodgkin's disease
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraductal papillary mucinous neoplasm
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraductal papillary-mucinous carcinoma of pancreas
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraductal proliferative breast lesion
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive breast carcinoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
2 / 13769 (0.01%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large cell lung cancer stage III
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal cancer
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal cancer stage 0
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal cancer stage IV
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lip and/or oral cavity cancer
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (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 stage III
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lip squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lipoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liposarcoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
subjects affected / exposed
|
13 / 13769 (0.09%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma metastatic
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma stage I
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma stage III
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma stage IV
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung cancer metastatic
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung carcinoma cell type unspecified stage I
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung carcinoma cell type unspecified stage II
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung carcinoma cell type unspecified stage III
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung carcinoma cell type unspecified stage IV
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung neoplasm
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung neoplasm malignant
|
|
|
subjects affected / exposed
|
19 / 13769 (0.14%) |
15 / 13756 (0.11%) |
occurrences causally related to treatment / all
|
0 / 21 |
1 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung squamous cell carcinoma metastatic
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung squamous cell carcinoma stage I
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung squamous cell carcinoma stage III
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphoma
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphoproliferative disorder
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant anorectal neoplasm
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant ascites
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma in situ
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma of sites other than skin
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant mesenteric neoplasm
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant neoplasm of pleura
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant neoplasm of renal pelvis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant peritoneal neoplasm
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant urinary tract neoplasm
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningioma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningioma benign
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesothelioma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesothelioma malignant
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to adrenals
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to bone
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to central nervous system
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to liver
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to lung
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to lymph nodes
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to pleura
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to spine
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastasis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic bronchial carcinoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic malignant melanoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelodysplastic syndrome
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelofibrosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm malignant
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm progression
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm prostate
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroendocrine carcinoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroendocrine carcinoma metastatic
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroendocrine tumour
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-small cell lung cancer
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-small cell lung cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal adenocarcinoma
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal adenocarcinoma metastatic
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oral cavity cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oral neoplasm
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oral papilloma
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oropharyngeal cancer
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oropharyngeal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian adenoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cancer
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cancer stage II
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian epithelial cancer
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
5 / 13769 (0.04%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic carcinoma metastatic
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papillary cystadenoma lymphomatosum
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papillary thyroid cancer
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parathyroid tumour benign
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Penile cancer
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phaeochromocytoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal cancer
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal cancer stage IV
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal neoplasm benign
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasmacytoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural mesothelioma malignant
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polycythaemia vera
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
subjects affected / exposed
|
41 / 13769 (0.30%) |
40 / 13756 (0.29%) |
occurrences causally related to treatment / all
|
3 / 42 |
0 / 42 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer metastatic
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
1 / 6 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer stage I
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer stage II
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer stage IV
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic adenoma
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
7 / 13756 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal cancer
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal cancer stage III
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal cancer stage IV
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal adenoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
subjects affected / exposed
|
9 / 13769 (0.07%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
1 / 11 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cancer stage I
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cell carcinoma
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cell carcinoma stage I
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cell carcinoma stage II
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cell carcinoma stage III
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal neoplasm
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal oncocytoma
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal neoplasm
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland adenoma
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sarcoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sarcoma metastatic
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Schwannoma
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
2 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small cell lung cancer
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small cell lung cancer limited stage
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small cell lung cancer metastatic
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestine carcinoma
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue sarcoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spindle cell sarcoma
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of head and neck
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
3 / 13769 (0.02%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of skin
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the oral cavity
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the tongue
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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 vulva
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid cancer
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tongue neoplasm malignant stage unspecified
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsil cancer
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transitional cell cancer of the renal pelvis and ureter
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transitional cell carcinoma
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tumour haemorrhage
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Undifferentiated sarcoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteral neoplasm
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine cancer
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vocal cord neoplasm
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulval cancer recurrent
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Accelerated hypertension
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aneurysm
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angiopathy
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angiosclerosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic aneurysm
|
|
|
subjects affected / exposed
|
27 / 13769 (0.20%) |
27 / 13756 (0.20%) |
occurrences causally related to treatment / all
|
0 / 28 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic aneurysm rupture
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic occlusion
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic stenosis
|
|
|
subjects affected / exposed
|
7 / 13769 (0.05%) |
8 / 13756 (0.06%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic thrombosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial occlusive disease
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial thrombosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
2 / 13769 (0.01%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure fluctuation
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cryoglobulinaemia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
7 / 13769 (0.05%) |
14 / 13756 (0.10%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic vascular disorder
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dry gangrene
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism arterial
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism venous
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
2 / 13769 (0.01%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Granulomatosis with polyangiitis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertension
|
|
|
subjects affected / exposed
|
56 / 13769 (0.41%) |
41 / 13756 (0.30%) |
occurrences causally related to treatment / all
|
2 / 59 |
1 / 41 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
subjects affected / exposed
|
15 / 13769 (0.11%) |
12 / 13756 (0.09%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotension
|
|
|
subjects affected / exposed
|
9 / 13769 (0.07%) |
13 / 13756 (0.09%) |
occurrences causally related to treatment / all
|
1 / 12 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemic shock
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iliac artery occlusion
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intermittent claudication
|
|
|
subjects affected / exposed
|
31 / 13769 (0.23%) |
22 / 13756 (0.16%) |
occurrences causally related to treatment / all
|
0 / 41 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Internal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphocele
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (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
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant hypertension
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurogenic shock
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
subjects affected / exposed
|
9 / 13769 (0.07%) |
7 / 13756 (0.05%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic venous thrombosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
94 / 13769 (0.68%) |
82 / 13756 (0.60%) |
occurrences causally related to treatment / all
|
1 / 113 |
0 / 96 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery aneurysm
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
7 / 13756 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery dissection
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery occlusion
|
|
|
subjects affected / exposed
|
20 / 13769 (0.15%) |
16 / 13756 (0.12%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
subjects affected / exposed
|
27 / 13769 (0.20%) |
33 / 13756 (0.24%) |
occurrences causally related to treatment / all
|
0 / 30 |
0 / 37 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral circulatory failure
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral embolism
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
subjects affected / exposed
|
35 / 13769 (0.25%) |
39 / 13756 (0.28%) |
occurrences causally related to treatment / all
|
0 / 41 |
0 / 47 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral vascular disorder
|
|
|
subjects affected / exposed
|
16 / 13769 (0.12%) |
9 / 13756 (0.07%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral venous disease
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Poor peripheral circulation
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renovascular hypertension
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shock
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shock haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian artery embolism
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian artery occlusion
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian artery stenosis
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian steal syndrome
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Superior vena cava syndrome
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Takayasu's arteritis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Temporal arteritis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thromboangiitis obliterans
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis superficial
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose ulceration
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose vein
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular insufficiency
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular occlusion
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stenosis
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vasodilatation
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vena cava thrombosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis limb
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
Abscess drainage
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve replacement
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia prophylaxis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial catheterisation
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula operation
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthma prophylaxis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac pacemaker insertion
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac rehabilitation therapy
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac resynchronisation therapy
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary arterial stent insertion
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery bypass
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary revascularisation
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Elective procedure
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterostomy
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture treatment
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric banding reversal
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemostasis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hospitalisation
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implantable defibrillator insertion
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incisional hernia repair
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia repair
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Knee arthroplasty
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestinal polypectomy
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine anastomosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leg amputation
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Open reduction of fracture
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Percutaneous coronary intervention
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery bypass
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plastic surgery to the face
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Preoperative care
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Proctectomy
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal anaesthesia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stent placement
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Therapy cessation
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toe amputation
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transcatheter aortic valve implantation
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia repair
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral operation
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
|
|
Asthenia
|
|
|
subjects affected / exposed
|
8 / 13769 (0.06%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breakthrough pain
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter site extravasation
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest discomfort
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest pain
|
|
|
subjects affected / exposed
|
42 / 13769 (0.31%) |
49 / 13756 (0.36%) |
occurrences causally related to treatment / all
|
0 / 43 |
1 / 53 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complication associated with device
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cyst rupture
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug intolerance
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug withdrawal syndrome
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Exercise tolerance decreased
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fat necrosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
2 / 13769 (0.01%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised oedema
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hernia
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implant site inflammation
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated hernia
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inflammation
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malaise
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mass
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device discomfort
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mucosal inflammation
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
109 / 13769 (0.79%) |
133 / 13756 (0.97%) |
occurrences causally related to treatment / all
|
1 / 125 |
0 / 152 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pacemaker generated arrhythmia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral swelling
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
9 / 13756 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sensation of foreign body
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue inflammation
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Strangulated hernia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden cardiac death
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical failure
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic inflammatory response syndrome
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent occlusion
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent restenosis
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent stenosis
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent thrombosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
Allergy to arthropod sting
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaphylactic reaction
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaphylactic shock
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug hypersensitivity
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Food allergy
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mite allergy
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sarcoidosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transplant rejection
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Social circumstances
|
|
|
Abstains from alcohol
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Disability
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Social stay hospitalisation
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Substance abuser
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Adnexa uteri mass
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign prostatic hyperplasia
|
|
|
subjects affected / exposed
|
30 / 13769 (0.22%) |
26 / 13756 (0.19%) |
occurrences causally related to treatment / all
|
0 / 30 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast dysplasia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast enlargement
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast pain
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical dysplasia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical polyp
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervix disorder
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystocele
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial hyperplasia
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial thickening
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Genital haemorrhage
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Male genital tract fistula
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Menorrhagia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metrorrhagia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cyst
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic pain
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postmenopausal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Priapism
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatomegaly
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive tract disorder
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scrotal cyst
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scrotal oedema
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spermatic cord inflammation
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine atony
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine enlargement
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine haemorrhage
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine polyp
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
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
|
3 / 13769 (0.02%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal haemorrhage
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal prolapse
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulvar dysplasia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulvovaginal pruritus
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Acquired diaphragmatic eventration
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
2 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute respiratory distress syndrome
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute respiratory failure
|
|
|
subjects affected / exposed
|
11 / 13769 (0.08%) |
13 / 13756 (0.09%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Apnoea
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthma
|
|
|
subjects affected / exposed
|
8 / 13769 (0.06%) |
11 / 13756 (0.08%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthma-chronic obstructive pulmonary disease overlap syndrome
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atelectasis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchial fistula
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis chronic
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (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 / 13769 (0.46%) |
64 / 13756 (0.47%) |
occurrences causally related to treatment / all
|
0 / 71 |
1 / 80 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic respiratory failure
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Combined pulmonary fibrosis and emphysema
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cough
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diaphragmatic paralysis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysphonia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
28 / 13769 (0.20%) |
18 / 13756 (0.13%) |
occurrences causally related to treatment / all
|
0 / 28 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea at rest
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
6 / 13769 (0.04%) |
11 / 13756 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Emphysema
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epiglottic cyst
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
subjects affected / exposed
|
10 / 13769 (0.07%) |
8 / 13756 (0.06%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
subjects affected / exposed
|
7 / 13769 (0.05%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemothorax
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiccups
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperventilation
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Idiopathic pulmonary fibrosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal oedema
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal cyst
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal obstruction
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal polyps
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal septum deviation
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal turbinate hypertrophy
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nocturnal dyspnoea
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oropharyngeal pain
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthopnoea
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal cyst
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pickwickian syndrome
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural adhesion
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural disorder
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
5 / 13769 (0.04%) |
11 / 13756 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleurisy
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleuritic pain
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
subjects affected / exposed
|
8 / 13769 (0.06%) |
7 / 13756 (0.05%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonitis
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
10 / 13756 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Productive cough
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary alveolar haemorrhage
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary arterial hypertension
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
20 / 13769 (0.15%) |
28 / 13756 (0.20%) |
occurrences causally related to treatment / all
|
0 / 20 |
1 / 29 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary fibrosis
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary hypertension
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary mass
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary pain
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory disorder
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory distress
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
subjects affected / exposed
|
16 / 13769 (0.12%) |
8 / 13756 (0.06%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sleep apnoea syndrome
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
13 / 13756 (0.09%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stridor
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper respiratory tract inflammation
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vocal cord leukoplakia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Acute psychosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Affective disorder
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol abuse
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol withdrawal syndrome
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcoholism
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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 / 13769 (0.03%) |
7 / 13756 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety disorder
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety disorder due to a general medical condition
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Burnout syndrome
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Confusional state
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Conversion disorder
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delirium
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delirium tremens
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
15 / 13769 (0.11%) |
20 / 13756 (0.15%) |
occurrences causally related to treatment / all
|
1 / 16 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression suicidal
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug abuse
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug dependence
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hallucination
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
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 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Major depression
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mania
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental disorder
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mood disorder due to a general medical condition
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
3 / 13769 (0.02%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Personality disorder
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric decompensation
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychogenic seizure
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychotic disorder
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Somatic symptom disorder
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicidal ideation
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicide attempt
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product issues
|
|
|
Device battery issue
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device breakage
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (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
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device failure
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device ineffective
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device leakage
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device loosening
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device malfunction
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device occlusion
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lead dislodgement
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis in device
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Acute hepatic failure
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ampulla of Vater stenosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Autoimmune hepatitis
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct obstruction
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct stenosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct stone
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary colic
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
1 / 5 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary cyst
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis acute
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
subjects affected / exposed
|
14 / 13769 (0.10%) |
7 / 13756 (0.05%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
subjects affected / exposed
|
40 / 13769 (0.29%) |
31 / 13756 (0.23%) |
occurrences causally related to treatment / all
|
1 / 40 |
0 / 31 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis chronic
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystocholangitis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
27 / 13769 (0.20%) |
23 / 13756 (0.17%) |
occurrences causally related to treatment / all
|
0 / 28 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis migration
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis obstructive
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholestasis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cirrhosis alcoholic
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
3 / 13769 (0.02%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder perforation
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cirrhosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cyst
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic failure
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic fibrosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic function abnormal
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic pain
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic steatosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis acute
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis toxic
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatorenal syndrome
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatotoxicity
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertransaminasaemia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaundice
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver disorder
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Porcelain gallbladder
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Portal vein thrombosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subacute hepatic failure
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Alanine aminotransferase increased
|
|
|
subjects affected / exposed
|
11 / 13769 (0.08%) |
15 / 13756 (0.11%) |
occurrences causally related to treatment / all
|
6 / 11 |
11 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriogram coronary
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriogram coronary abnormal
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriogram coronary normal
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aspartate aminotransferase increased
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
11 / 13756 (0.08%) |
occurrences causally related to treatment / all
|
1 / 6 |
7 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood alkaline phosphatase increased
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood bilirubin increased
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatine phosphokinase increased
|
|
|
subjects affected / exposed
|
7 / 13769 (0.05%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
5 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood glucose decreased
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood glucose fluctuation
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood glucose increased
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood potassium increased
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure increased
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac stress test abnormal
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
4 / 13769 (0.03%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram QT prolonged
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram ST segment depression
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram abnormal
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Exercise electrocardiogram abnormal
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
False positive investigation result
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart rate increased
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart rate irregular
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
subjects affected / exposed
|
24 / 13769 (0.17%) |
8 / 13756 (0.06%) |
occurrences causally related to treatment / all
|
14 / 25 |
4 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis A antibody positive
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis A virus test positive
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis B antibody positive
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis C virus test positive
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza A virus test positive
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza B virus test positive
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
International normalised ratio abnormal
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
International normalised ratio increased
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigation
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lipase increased
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver function test abnormal
|
|
|
subjects affected / exposed
|
7 / 13769 (0.05%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
3 / 7 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver function test increased
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
7 / 13756 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical observation
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial necrosis marker increased
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oxygen saturation decreased
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Precancerous cells present
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress echocardiogram
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid function test abnormal
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transaminases increased
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
2 / 7 |
2 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Troponin I increased
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Troponin T increased
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
3 / 13769 (0.02%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Weight decreased
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Weight increased
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
Abdominal injury
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
3 / 13769 (0.02%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acetabulum fracture
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol poisoning
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia postoperative
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anastomotic fistula
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anastomotic leak
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anastomotic stenosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Animal bite
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Animal scratch
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
subjects affected / exposed
|
8 / 13769 (0.06%) |
12 / 13756 (0.09%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic injury
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial bypass occlusion
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial bypass thrombosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial injury
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial restenosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula site complication
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthropod bite
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Avulsion fracture
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carbon monoxide poisoning
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery restenosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cartilage injury
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
4 / 13769 (0.03%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chemical burn of gastrointestinal tract
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chemical poisoning
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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 / 13769 (0.00%) |
1 / 13756 (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
|
3 / 13769 (0.02%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Comminuted fracture
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Concussion
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Contusion
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery restenosis
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cranial nerve injury
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
6 / 13769 (0.04%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diffuse axonal injury
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dislocation of sternum
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dislocation of vertebra
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endotracheal intubation complication
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye contusion
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye operation complication
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Face injury
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
subjects affected / exposed
|
17 / 13769 (0.12%) |
13 / 13756 (0.09%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
7 / 13756 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
subjects affected / exposed
|
20 / 13769 (0.15%) |
9 / 13756 (0.07%) |
occurrences causally related to treatment / all
|
1 / 20 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Forearm fracture
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foreign body aspiration
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture displacement
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fractured ischium
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fractured sacrum
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft complication
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft thrombosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hand fracture
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head injury
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
8 / 13756 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heat exhaustion
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heat stroke
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
11 / 13769 (0.08%) |
11 / 13756 (0.08%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
8 / 13756 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ilium fracture
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incomplete spinal fusion
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inflammation of wound
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
5 / 13769 (0.04%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intentional overdose
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaw fracture
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint dislocation postoperative
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint injury
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kidney contusion
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laceration
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament rupture
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb crushing injury
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb fracture
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb injury
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb traumatic amputation
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
subjects affected / exposed
|
7 / 13769 (0.05%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medication error
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
subjects affected / exposed
|
8 / 13769 (0.06%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 8 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metal poisoning
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple fractures
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (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
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle contusion
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle rupture
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neck injury
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Open globe injury
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Overdose
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Patella fracture
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral arterial reocclusion
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery restenosis
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
3 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perirenal haematoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peroneal nerve palsy postoperative
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumoconiosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonitis chemical
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Poisoning
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post concussion syndrome
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post laminectomy syndrome
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural complication
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural constipation
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematuria
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
7 / 13756 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural myocardial infarction
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural swelling
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post-traumatic neck syndrome
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative respiratory failure
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative thoracic procedure complication
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound complication
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural complication
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural haemorrhage
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural hypotension
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural pain
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural pneumothorax
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pubis fracture
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radial head dislocation
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiation mucositis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiation oesophagitis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
subjects affected / exposed
|
7 / 13769 (0.05%) |
11 / 13756 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sacroiliac fracture
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scapula fracture
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seroma
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skeletal injury
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin abrasion
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skull fracture
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skull fractured base
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Snake bite
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal column injury
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal cord injury
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal cord injury lumbar
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic injury
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stab wound
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sternal fracture
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous haematoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
6 / 13769 (0.04%) |
11 / 13756 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
1 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural haemorrhage
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon injury
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
8 / 13756 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thermal burn
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
subjects affected / exposed
|
7 / 13769 (0.05%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transplant failure
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic arthritis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic fracture
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic haematoma
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic haemothorax
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic intracranial haemorrhage
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic shock
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic ulcer
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulnar nerve injury
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral stricture postoperative
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular bypass dysfunction
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft complication
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft occlusion
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft thrombosis
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular procedure complication
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound evisceration
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound haemorrhage
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound necrosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound secretion
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
Adenomatous polyposis coli
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous malformation
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial septal defect
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carbohydrate metabolism disorder
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Corneal dystrophy
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Exomphalos
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal arteriovenous malformation
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hereditary motor and sensory neuropathy
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocele
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertrophic cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracranial lipoma
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subependymal nodular heterotopia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Acute coronary syndrome
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
11 / 13756 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute left ventricular failure
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute myocardial infarction
|
|
|
subjects affected / exposed
|
11 / 13769 (0.08%) |
23 / 13756 (0.17%) |
occurrences causally related to treatment / all
|
0 / 11 |
1 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
subjects affected / exposed
|
208 / 13769 (1.51%) |
221 / 13756 (1.61%) |
occurrences causally related to treatment / all
|
4 / 240 |
6 / 250 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
subjects affected / exposed
|
233 / 13769 (1.69%) |
278 / 13756 (2.02%) |
occurrences causally related to treatment / all
|
4 / 273 |
3 / 314 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve disease
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve incompetence
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve stenosis
|
|
|
subjects affected / exposed
|
10 / 13769 (0.07%) |
8 / 13756 (0.06%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia supraventricular
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteritis coronary
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
119 / 13769 (0.86%) |
132 / 13756 (0.96%) |
occurrences causally related to treatment / all
|
0 / 157 |
2 / 155 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
subjects affected / exposed
|
25 / 13769 (0.18%) |
17 / 13756 (0.12%) |
occurrences causally related to treatment / all
|
0 / 27 |
1 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial tachycardia
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial thrombosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block complete
|
|
|
subjects affected / exposed
|
16 / 13769 (0.12%) |
13 / 13756 (0.09%) |
occurrences causally related to treatment / all
|
0 / 16 |
1 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block first degree
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block second degree
|
|
|
subjects affected / exposed
|
7 / 13769 (0.05%) |
7 / 13756 (0.05%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bifascicular block
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradyarrhythmia
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
10 / 13769 (0.07%) |
13 / 13756 (0.09%) |
occurrences causally related to treatment / all
|
1 / 10 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bundle branch block bilateral
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bundle branch block left
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bundle branch block right
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac aneurysm
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac asthma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorder
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure
|
|
|
subjects affected / exposed
|
66 / 13769 (0.48%) |
66 / 13756 (0.48%) |
occurrences causally related to treatment / all
|
0 / 71 |
1 / 73 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure acute
|
|
|
subjects affected / exposed
|
13 / 13769 (0.09%) |
10 / 13756 (0.07%) |
occurrences causally related to treatment / all
|
0 / 13 |
1 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure chronic
|
|
|
subjects affected / exposed
|
50 / 13769 (0.36%) |
47 / 13756 (0.34%) |
occurrences causally related to treatment / all
|
0 / 53 |
0 / 56 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure congestive
|
|
|
subjects affected / exposed
|
46 / 13769 (0.33%) |
37 / 13756 (0.27%) |
occurrences causally related to treatment / all
|
0 / 48 |
0 / 40 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac flutter
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac tamponade
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac ventricular thrombosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiogenic shock
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiomyopathy
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiopulmonary failure
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiorenal syndrome
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiotoxicity
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiovascular disorder
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congestive cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
subjects affected / exposed
|
32 / 13769 (0.23%) |
46 / 13756 (0.33%) |
occurrences causally related to treatment / all
|
0 / 33 |
0 / 48 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery occlusion
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery thrombosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diastolic dysfunction
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extrasystoles
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart alternation
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart valve incompetence
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive heart disease
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracardiac thrombus
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic cardiomyopathy
|
|
|
subjects affected / exposed
|
7 / 13769 (0.05%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left ventricular dysfunction
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
7 / 13756 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left ventricular failure
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Microvascular coronary artery disease
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
subjects affected / exposed
|
11 / 13769 (0.08%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve stenosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
subjects affected / exposed
|
31 / 13769 (0.23%) |
31 / 13756 (0.23%) |
occurrences causally related to treatment / all
|
1 / 31 |
1 / 31 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial ischaemia
|
|
|
subjects affected / exposed
|
26 / 13769 (0.19%) |
21 / 13756 (0.15%) |
occurrences causally related to treatment / all
|
0 / 26 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial necrosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocarditis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Palpitations
|
|
|
subjects affected / exposed
|
7 / 13769 (0.05%) |
8 / 13756 (0.06%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prinzmetal angina
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulseless electrical activity
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhythm idioventricular
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Silent myocardial infarction
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus arrest
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus node dysfunction
|
|
|
subjects affected / exposed
|
17 / 13769 (0.12%) |
18 / 13756 (0.13%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus tachycardia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
9 / 13769 (0.07%) |
9 / 13756 (0.07%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Torsade de pointes
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular arrhythmia
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular extrasystoles
|
|
|
subjects affected / exposed
|
7 / 13769 (0.05%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular fibrillation
|
|
|
subjects affected / exposed
|
12 / 13769 (0.09%) |
8 / 13756 (0.06%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular hypertrophy
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular tachyarrhythmia
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular tachycardia
|
|
|
subjects affected / exposed
|
23 / 13769 (0.17%) |
27 / 13756 (0.20%) |
occurrences causally related to treatment / all
|
0 / 30 |
0 / 33 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
Altered state of consciousness
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Amnesia
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Amputation stump pain
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Amyotrophic lateral sclerosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aphasia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Apraxia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arachnoid cyst
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ataxia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Balance disorder
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal ganglia infarction
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basilar artery aneurysm
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basilar artery stenosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
5 / 13769 (0.04%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery disease
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery occlusion
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
7 / 13756 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
subjects affected / exposed
|
37 / 13769 (0.27%) |
39 / 13756 (0.28%) |
occurrences causally related to treatment / all
|
2 / 39 |
0 / 43 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cauda equina syndrome
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar ataxia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar infarction
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral artery occlusion
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral artery stenosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral atrophy
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haematoma
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral infarction
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral ischaemia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral thrombosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral vasoconstriction
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
25 / 13769 (0.18%) |
21 / 13756 (0.15%) |
occurrences causally related to treatment / all
|
1 / 26 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular disorder
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular insufficiency
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical cord compression
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical myelopathy
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical radiculopathy
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervicobrachial syndrome
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervicogenic headache
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complex partial seizures
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia Alzheimer's type
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Demyelinating polyneuropathy
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic neuropathy
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness
|
|
|
subjects affected / exposed
|
15 / 13769 (0.11%) |
19 / 13756 (0.14%) |
occurrences causally related to treatment / all
|
1 / 15 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness postural
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysarthria
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dystonia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalitis autoimmune
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
7 / 13756 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial paralysis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised tonic-clonic seizure
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Guillain-Barre syndrome
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Headache
|
|
|
subjects affected / exposed
|
9 / 13769 (0.07%) |
17 / 13756 (0.12%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiplegic migraine
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic encephalopathy
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocephalus
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive encephalopathy
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertonia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoaesthesia
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic coma
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic encephalopathy
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic unconsciousness
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
IIIrd nerve paralysis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracranial aneurysm
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracranial mass
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lacunar infarction
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lacunar stroke
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lethargy
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
7 / 13756 (0.05%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar radiculopathy
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbosacral radiculopathy
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meralgia paraesthetica
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Migraine
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Migraine with aura
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Monoparesis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Motor neurone disease
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve compression
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorder
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuralgia
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuritis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroglycopenia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuromuscular pain
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraesthesia
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraparesis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paresis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parkinsonism
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Partial seizures
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral motor neuropathy
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral sensory neuropathy
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peroneal nerve palsy
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Petit mal epilepsy
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (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 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyneuropathy idiopathic progressive
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postictal state
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Presyncope
|
|
|
subjects affected / exposed
|
9 / 13769 (0.07%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudoradicular syndrome
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychomotor hyperactivity
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Quadriplegia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radicular syndrome
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiculopathy
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retrograde amnesia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sciatica
|
|
|
subjects affected / exposed
|
14 / 13769 (0.10%) |
10 / 13756 (0.07%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sedation
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seizure
|
|
|
subjects affected / exposed
|
8 / 13769 (0.06%) |
13 / 13756 (0.09%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Speech disorder
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal claudication
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal cord compression
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Status epilepticus
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stroke in evolution
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural effusion
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Syncope
|
|
|
subjects affected / exposed
|
63 / 13769 (0.46%) |
56 / 13756 (0.41%) |
occurrences causally related to treatment / all
|
2 / 64 |
0 / 59 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tarsal tunnel syndrome
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tension headache
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thoracic outlet syndrome
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic encephalopathy
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
subjects affected / exposed
|
42 / 13769 (0.31%) |
36 / 13756 (0.26%) |
occurrences causally related to treatment / all
|
1 / 43 |
0 / 36 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Unresponsive to stimuli
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular encephalopathy
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral artery occlusion
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebrobasilar insufficiency
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo CNS origin
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual field defect
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vocal cord paralysis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
subjects affected / exposed
|
27 / 13769 (0.20%) |
27 / 13756 (0.20%) |
occurrences causally related to treatment / all
|
0 / 28 |
0 / 27 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia of chronic disease
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Autoimmune haemolytic anaemia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coagulopathy
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Febrile neutropenia
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic anaemia
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic disorder
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypochromic anaemia
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune thrombocytopenic purpura
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
1 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iron deficiency anaemia
|
|
|
subjects affected / exposed
|
9 / 13769 (0.07%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenitis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenopathy
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenopathy mediastinal
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Microcytic anaemia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normochromic normocytic anaemia
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pernicious anaemia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polycythaemia
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spleen disorder
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
Acute vestibular syndrome
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deafness
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deafness neurosensory
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deafness unilateral
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoacusis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inner ear inflammation
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniere's disease
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otorrhoea
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden hearing loss
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tinnitus
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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 / 13769 (0.07%) |
13 / 13756 (0.09%) |
occurrences causally related to treatment / all
|
0 / 9 |
1 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
subjects affected / exposed
|
7 / 13769 (0.05%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular disorder
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular ischaemia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Angle closure glaucoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blepharochalasis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract
|
|
|
subjects affected / exposed
|
15 / 13769 (0.11%) |
22 / 13756 (0.16%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract nuclear
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dacryoadenitis acquired
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ectropion
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eyelid ptosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glaucoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iridocyclitis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (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
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular fibrosis
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ocular myasthenia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ophthalmoplegia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pterygium
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal artery occlusion
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal artery thrombosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal tear
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal vascular disorder
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal vein thrombosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Strabismus
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uveitis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual acuity reduced
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual impairment
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous floaters
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous haemorrhage
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Abdominal adhesions
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal discomfort
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal distension
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal hernia
|
|
|
subjects affected / exposed
|
11 / 13769 (0.08%) |
8 / 13756 (0.06%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
subjects affected / exposed
|
12 / 13769 (0.09%) |
19 / 13756 (0.14%) |
occurrences causally related to treatment / all
|
1 / 13 |
3 / 22 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain lower
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
subjects affected / exposed
|
12 / 13769 (0.09%) |
13 / 13756 (0.09%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall haematoma
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcoholic pancreatitis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fissure
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fistula
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal incontinence
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anastomotic ulcer perforation
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ascites
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Barrett's oesophagus
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic gastritis
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coeliac artery stenosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
8 / 13756 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
subjects affected / exposed
|
10 / 13769 (0.07%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ulcerative
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colonic fistula
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Constipation
|
|
|
subjects affected / exposed
|
9 / 13769 (0.07%) |
9 / 13756 (0.07%) |
occurrences causally related to treatment / all
|
1 / 9 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Crohn's disease
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
subjects affected / exposed
|
9 / 13769 (0.07%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenitis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
subjects affected / exposed
|
7 / 13769 (0.05%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epiploic appendagitis
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erosive oesophagitis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Faecaloma
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Food poisoning
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric cyst
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric disorder
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
subjects affected / exposed
|
9 / 13769 (0.07%) |
8 / 13756 (0.06%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
subjects affected / exposed
|
7 / 13769 (0.05%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer perforation
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
19 / 13769 (0.14%) |
17 / 13756 (0.12%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis alcoholic
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroduodenal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal angiodysplasia
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal angiodysplasia haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
27 / 13769 (0.20%) |
16 / 13756 (0.12%) |
occurrences causally related to treatment / all
|
0 / 27 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal pain
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal polyp haemorrhage
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal ulcer
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
subjects affected / exposed
|
14 / 13769 (0.10%) |
15 / 13756 (0.11%) |
occurrences causally related to treatment / all
|
0 / 14 |
1 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematochezia
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic erosive gastritis
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
10 / 13756 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoids thrombosed
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hernial eventration
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
subjects affected / exposed
|
9 / 13769 (0.07%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
7 / 13756 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus paralytic
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired gastric emptying
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated inguinal hernia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated umbilical hernia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inflammatory bowel disease
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
32 / 13769 (0.23%) |
22 / 13756 (0.16%) |
occurrences causally related to treatment / all
|
0 / 34 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal dilatation
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal ischaemia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal polyp
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal prolapse
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intra-abdominal fluid collection
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intra-abdominal haematoma
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intra-abdominal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intussusception
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Irritable bowel syndrome
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestinal obstruction
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestinal ulcer
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
10 / 13769 (0.07%) |
16 / 13756 (0.12%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukoplakia oral
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mallory-Weiss syndrome
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mechanical ileus
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melaena
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric arterial occlusion
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric artery stenosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric artery thrombosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric vein thrombosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
5 / 13769 (0.04%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Odynophagia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal food impaction
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal obstruction
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal spasm
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal stenosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal ulcer
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal varices haemorrhage
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
1 / 13769 (0.01%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis ulcerative
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Palatal swelling
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic cyst
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic disorder
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic necrosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic phlegmon
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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 / 13769 (0.01%) |
0 / 13756 (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
|
10 / 13769 (0.07%) |
16 / 13756 (0.12%) |
occurrences causally related to treatment / all
|
1 / 10 |
1 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
subjects affected / exposed
|
14 / 13769 (0.10%) |
22 / 13756 (0.16%) |
occurrences causally related to treatment / all
|
1 / 16 |
5 / 28 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis chronic
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis necrotising
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatolithiasis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
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 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periodontal disease
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal haematoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Proctitis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
9 / 13756 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal polyp
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reflux gastritis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retching
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal fibrosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal haematoma
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland enlargement
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestine ulcer
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Strangulated umbilical hernia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress ulcer
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis mesenteric vessel
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tongue cyst
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tongue oedema
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth disorder
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth impacted
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
subjects affected / exposed
|
10 / 13769 (0.07%) |
14 / 13756 (0.10%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
13 / 13769 (0.09%) |
9 / 13756 (0.07%) |
occurrences causally related to treatment / all
|
0 / 13 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varices oesophageal
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Volvulus
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vomiting
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
10 / 13756 (0.07%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Angioedema
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decubitus ulcer
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermal cyst
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis allergic
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis contact
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis exfoliative
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatomyositis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
7 / 13756 (0.05%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug eruption
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dry skin
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eczema
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eczema nummular
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Excessive granulation tissue
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Excessive skin
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Henoch-Schonlein purpura
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperhidrosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ingrowing nail
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lichen myxoedematosus
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lichen planus
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papulopustular rosacea
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pemphigoid
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pruritus
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pruritus generalised
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psoriasis
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scar pain
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin exfoliation
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stasis dermatitis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous emphysema
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Swelling face
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urticaria
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
Acute kidney injury
|
|
|
subjects affected / exposed
|
64 / 13769 (0.46%) |
64 / 13756 (0.47%) |
occurrences causally related to treatment / all
|
3 / 69 |
0 / 66 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute prerenal failure
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Azotaemia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder dilatation
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neck obstruction
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder obstruction
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder outlet obstruction
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder spasm
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder tamponade
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus bladder
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus urethral
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus urinary
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
subjects affected / exposed
|
17 / 13769 (0.12%) |
15 / 13756 (0.11%) |
occurrences causally related to treatment / all
|
1 / 17 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic nephropathy
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysuria
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
End stage renal disease
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glomerulonephritis chronic
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glomerulonephritis membranous
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematuria
|
|
|
subjects affected / exposed
|
17 / 13769 (0.12%) |
12 / 13756 (0.09%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage urinary tract
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
16 / 13769 (0.12%) |
29 / 13756 (0.21%) |
occurrences causally related to treatment / all
|
0 / 16 |
1 / 31 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephropathy toxic
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrotic syndrome
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurogenic bladder
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nocturia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive uropathy
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prerenal failure
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelocaliectasis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery stenosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal colic
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cyst
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cyst haemorrhage
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal infarct
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal mass
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal pain
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress urinary incontinence
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tubulointerstitial nephritis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric rupture
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureterolithiasis
|
|
|
subjects affected / exposed
|
9 / 13769 (0.07%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary incontinence
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
subjects affected / exposed
|
14 / 13769 (0.10%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinoma
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Adrenal insufficiency
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal mass
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basedow's disease
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Goitre
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperparathyroidism
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperparathyroidism primary
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperthyroidism
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoaldosteronism
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inappropriate antidiuretic hormone secretion
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid mass
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Arthralgia
|
|
|
subjects affected / exposed
|
16 / 13769 (0.12%) |
18 / 13756 (0.13%) |
occurrences causally related to treatment / all
|
0 / 16 |
1 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis
|
|
|
subjects affected / exposed
|
11 / 13769 (0.08%) |
13 / 13756 (0.09%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthropathy
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back pain
|
|
|
subjects affected / exposed
|
30 / 13769 (0.22%) |
30 / 13756 (0.22%) |
occurrences causally related to treatment / all
|
0 / 32 |
0 / 31 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone deformity
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone pain
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical spinal stenosis
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondrocalcinosis pyrophosphate
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondropathy
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Costochondritis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic amyotrophy
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dupuytren's contracture
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enthesopathy
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Exostosis of jaw
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facet joint syndrome
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoroacetabular impingement
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibromyalgia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Flank pain
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot deformity
|
|
|
subjects affected / exposed
|
7 / 13769 (0.05%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture nonunion
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gouty arthritis
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin pain
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc degeneration
|
|
|
subjects affected / exposed
|
8 / 13769 (0.06%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc disorder
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc displacement
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
22 / 13769 (0.16%) |
24 / 13756 (0.17%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaw cyst
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint adhesion
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint effusion
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint instability
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint range of motion decreased
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint swelling
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb discomfort
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
21 / 13769 (0.15%) |
17 / 13756 (0.12%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mobility decreased
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Monarthritis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle spasms
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
49 / 13769 (0.36%) |
37 / 13756 (0.27%) |
occurrences causally related to treatment / all
|
0 / 54 |
1 / 40 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal stiffness
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myalgia
|
|
|
subjects affected / exposed
|
8 / 13769 (0.06%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
4 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myalgia intercostal
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myofascitis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myopathy
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myositis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neck pain
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathic arthropathy
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nodal osteoarthritis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteitis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
91 / 13769 (0.66%) |
100 / 13756 (0.73%) |
occurrences causally related to treatment / all
|
1 / 93 |
0 / 109 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteochondritis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteolysis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoporosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoporotic fracture
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
subjects affected / exposed
|
8 / 13769 (0.06%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in jaw
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Patellofemoral pain syndrome
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pathological fracture
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periarthritis
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyarthritis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polymyalgia rheumatica
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polymyositis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudarthrosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psoriatic arthropathy
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
7 / 13756 (0.05%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rheumatoid arthritis
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
1 / 3 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
subjects affected / exposed
|
8 / 13769 (0.06%) |
9 / 13756 (0.07%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seronegative arthritis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal column stenosis
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal instability
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
subjects affected / exposed
|
9 / 13769 (0.07%) |
12 / 13756 (0.09%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal pain
|
|
|
subjects affected / exposed
|
8 / 13769 (0.06%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylitis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondyloarthropathy
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
3 / 13769 (0.02%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylolysis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sympathetic posterior cervical syndrome
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Symphysiolysis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Synovial cyst
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Synovitis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Temporomandibular joint syndrome
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon necrosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendonitis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Trigger finger
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral foraminal stenosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral osteophyte
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Abdominal abscess
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal sepsis
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall abscess
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess bacterial
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
subjects affected / exposed
|
10 / 13769 (0.07%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess of eyelid
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess of salivary gland
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess soft tissue
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Amoebic dysentery
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fistula infection
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendiceal abscess
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
subjects affected / exposed
|
20 / 13769 (0.15%) |
14 / 13756 (0.10%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis perforated
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteritis infective
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atypical pneumonia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial pericarditis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial prostatitis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial pyelonephritis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial sepsis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacteroides bacteraemia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Beta haemolytic streptococcal infection
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone abscess
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast abscess
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
subjects affected / exposed
|
17 / 13769 (0.12%) |
30 / 13756 (0.22%) |
occurrences causally related to treatment / all
|
1 / 17 |
1 / 30 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis bacterial
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Burkholderia cepacia complex infection
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Burkholderia pseudomallei infection
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis infective
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Campylobacter gastroenteritis
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carbuncle
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter site infection
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
subjects affected / exposed
|
39 / 13769 (0.28%) |
28 / 13756 (0.20%) |
occurrences causally related to treatment / all
|
1 / 43 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis gangrenous
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis infective
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic hepatitis B
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic sinusitis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
6 / 13769 (0.04%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile infection
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colonic abscess
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Creutzfeldt-Jakob disease
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis escherichia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dengue fever
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related infection
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related sepsis
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot infection
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gangrene
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea infectious
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
subjects affected / exposed
|
16 / 13769 (0.12%) |
26 / 13756 (0.19%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 29 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eczema infected
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolic pneumonia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Empyema
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalitis viral
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis bacterial
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis haemophilus
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endophthalmitis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis infectious
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterobacter bacteraemia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterococcal bacteraemia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterococcal sepsis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epididymitis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epiglottitis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
subjects affected / exposed
|
16 / 13769 (0.12%) |
19 / 13756 (0.14%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erysipeloid
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia bacteraemia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Febrile infection
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fungal peritonitis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Furuncle
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder empyema
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gangrene
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
12 / 13756 (0.09%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis viral
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
19 / 13769 (0.14%) |
14 / 13756 (0.10%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis adenovirus
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis bacterial
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis clostridial
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis rotavirus
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis salmonella
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal infection
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gingival abscess
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft infection
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin abscess
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
H1N1 influenza
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma infection
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Helicobacter infection
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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 / 13769 (0.00%) |
1 / 13756 (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 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis C
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis E
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implant site infection
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incision site infection
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected bite
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected cyst
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected skin ulcer
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection in an immunocompromised host
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infectious colitis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infectious pleural effusion
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective exacerbation of chronic obstructive airways disease
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective tenosynovitis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza
|
|
|
subjects affected / exposed
|
9 / 13769 (0.07%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral discitis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kidney infection
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngitis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver abscess
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Localised infection
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
14 / 13769 (0.10%) |
15 / 13756 (0.11%) |
occurrences causally related to treatment / all
|
1 / 15 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower respiratory tract infection viral
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung abscess
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung infection
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mastoiditis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mediastinitis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device site infection
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis bacterial
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis pneumococcal
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasopharyngitis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurosyphilis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenic infection
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nosocomial infection
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ophthalmic herpes zoster
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oral fungal infection
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orchitis
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
subjects affected / exposed
|
16 / 13769 (0.12%) |
7 / 13756 (0.05%) |
occurrences causally related to treatment / all
|
1 / 18 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis acute
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis chronic
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis externa
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis externa bacterial
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis media
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreas infection
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paronychia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parotitis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perineal abscess
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periodontitis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perirectal abscess
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis bacterial
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal abscess
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngitis streptococcal
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumococcal sepsis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
147 / 13769 (1.07%) |
152 / 13756 (1.10%) |
occurrences causally related to treatment / all
|
1 / 154 |
1 / 162 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia adenoviral
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia bacterial
|
|
|
subjects affected / exposed
|
18 / 13769 (0.13%) |
11 / 13756 (0.08%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia influenzal
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia legionella
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia pneumococcal
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia staphylococcal
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia viral
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural infection
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural pneumonia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural sepsis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative abscess
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
8 / 13756 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate infection
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic abscess
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudomembranous colitis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psoas abscess
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary tuberculosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
10 / 13769 (0.07%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis chronic
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyonephrosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal abscess
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
subjects affected / exposed
|
8 / 13769 (0.06%) |
8 / 13756 (0.06%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection bacterial
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhinitis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhinovirus infection
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salpingitis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scrotal abscess
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scrotal infection
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sepsis
|
|
|
subjects affected / exposed
|
21 / 13769 (0.15%) |
31 / 13756 (0.23%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 32 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Septic shock
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
9 / 13756 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinusitis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin bacterial infection
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin infection
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue infection
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spermatic cord funiculitis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic abscess
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal abscess
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal bacteraemia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal infection
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcal sepsis
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous abscess
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Testicular abscess
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tick-borne viral encephalitis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsillitis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth abscess
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheitis
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheobronchitis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tuberculosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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 / 13769 (0.04%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper respiratory tract infection bacterial
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteritis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
41 / 13769 (0.30%) |
37 / 13756 (0.27%) |
occurrences causally related to treatment / all
|
0 / 48 |
0 / 42 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection bacterial
|
|
|
subjects affected / exposed
|
7 / 13769 (0.05%) |
7 / 13756 (0.05%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
subjects affected / exposed
|
12 / 13769 (0.09%) |
15 / 13756 (0.11%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular neuronitis
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral infection
|
|
|
subjects affected / exposed
|
4 / 13769 (0.03%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral myocarditis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral pericarditis
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral upper respiratory tract infection
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulval abscess
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound abscess
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
6 / 13769 (0.04%) |
11 / 13756 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection bacterial
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection staphylococcal
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound sepsis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Abnormal loss of weight
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (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
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decreased appetite
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dehydration
|
|
|
subjects affected / exposed
|
16 / 13769 (0.12%) |
18 / 13756 (0.13%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
subjects affected / exposed
|
61 / 13769 (0.44%) |
56 / 13756 (0.41%) |
occurrences causally related to treatment / all
|
2 / 71 |
3 / 60 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus inadequate control
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
11 / 13756 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
subjects affected / exposed
|
10 / 13769 (0.07%) |
8 / 13756 (0.06%) |
occurrences causally related to treatment / all
|
0 / 10 |
1 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic metabolic decompensation
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
3 / 13756 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrolyte imbalance
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fluid retention
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glucose tolerance impaired
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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
|
6 / 13769 (0.04%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperammonaemia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
8 / 13769 (0.06%) |
8 / 13756 (0.06%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperinsulinaemic hypoglycaemia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
subjects affected / exposed
|
10 / 13769 (0.07%) |
7 / 13756 (0.05%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypernatraemia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperosmolar hyperglycaemic state
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypocalcaemia
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
17 / 13769 (0.12%) |
11 / 13756 (0.08%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemia unawareness
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
6 / 13769 (0.04%) |
7 / 13756 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypomagnesaemia
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
5 / 13769 (0.04%) |
5 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovitaminosis
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ketoacidosis
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (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 / 13769 (0.00%) |
2 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic acidosis
|
|
|
subjects affected / exposed
|
2 / 13769 (0.01%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obesity
|
|
|
subjects affected / exposed
|
3 / 13769 (0.02%) |
6 / 13756 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 1 diabetes mellitus
|
|
|
subjects affected / exposed
|
0 / 13769 (0.00%) |
1 / 13756 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
subjects affected / exposed
|
12 / 13769 (0.09%) |
4 / 13756 (0.03%) |
occurrences causally related to treatment / all
|
0 / 12 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitamin B12 deficiency
|
|
|
subjects affected / exposed
|
1 / 13769 (0.01%) |
0 / 13756 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |