Serious adverse events
|
Placebo |
Empagliflozin 10 mg |
Empagliflozin 25 mg |
All Empagliflozin |
Total subjects affected by serious adverse events
|
|
|
|
|
subjects affected / exposed
|
988 / 2333 (42.35%) |
876 / 2345 (37.36%) |
913 / 2342 (38.98%) |
1789 / 4687 (38.17%) |
number of deaths (all causes)
|
119 |
97 |
79 |
176 |
number of deaths resulting from adverse events
|
2 |
3 |
1 |
4 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
|
Acoustic neuroma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
3 / 2345 (0.13%) |
0 / 2342 (0.00%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute lymphocytic leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Acute myeloid leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Adenocarcinoma gastric
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
2 / 2345 (0.09%) |
2 / 2342 (0.09%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Adenocarcinoma pancreas
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
3 / 2345 (0.13%) |
3 / 2342 (0.13%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
0 / 4 |
Adenoma benign
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anogenital warts
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
B-cell lymphoma
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
16 / 2333 (0.69%) |
15 / 2345 (0.64%) |
12 / 2342 (0.51%) |
27 / 4687 (0.58%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 17 |
0 / 12 |
0 / 29 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Basosquamous carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign hepatic neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign laryngeal neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign lung neoplasm
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign neoplasm of adrenal gland
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign neoplasm of bladder
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign neoplasm of prostate
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign neoplasm of thyroid gland
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign pancreatic neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign respiratory tract neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign uterine neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
5 / 2342 (0.21%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 5 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
Bladder cancer recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bone cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bone giant cell tumour benign
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bowen's disease
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Breast cancer
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
2 / 2345 (0.09%) |
2 / 2342 (0.09%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac myxoma
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervix carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholesteatoma
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic lymphocytic leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
3 / 2345 (0.13%) |
0 / 2342 (0.00%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clear cell renal cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colon adenoma
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
5 / 2345 (0.21%) |
1 / 2342 (0.04%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
Colon cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
3 / 2342 (0.13%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 3 |
Colon neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colorectal adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colorectal cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Fibroadenoma of breast
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fibrosarcoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Follicular thyroid cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal stromal tumour
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Genital neoplasm malignant female
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemangioma of bone
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemangioma of liver
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatocellular carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
3 / 2345 (0.13%) |
1 / 2342 (0.04%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
Hodgkin's disease stage I
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intraductal proliferative breast lesion
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Invasive ductal breast carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Keratoacanthoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Large cell lung cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Laryngeal cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Laryngeal squamous cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Lipoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
5 / 2345 (0.21%) |
3 / 2342 (0.13%) |
8 / 4687 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 3 |
Lung cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Lung carcinoma cell type unspecified stage III
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung neoplasm malignant
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
1 / 2345 (0.04%) |
7 / 2342 (0.30%) |
8 / 4687 (0.17%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 4 |
0 / 4 |
Lung squamous cell carcinoma stage III
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymphocytic lymphoma
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymphoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymphoproliferative disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
3 / 2345 (0.13%) |
3 / 2342 (0.13%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant melanoma in situ
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant neoplasm of unknown primary site
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningioma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant neoplasm progression
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to bone
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to liver
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
5 / 2345 (0.21%) |
5 / 2342 (0.21%) |
10 / 4687 (0.21%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 5 |
0 / 5 |
0 / 10 |
deaths causally related to treatment / all
|
1 / 2 |
0 / 1 |
0 / 3 |
0 / 4 |
Metastases to lung
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
2 / 2345 (0.09%) |
2 / 2342 (0.09%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Metastases to lymph nodes
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to peritoneum
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Metastases to neck
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to pleura
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastasis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Metastatic malignant melanoma
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myelodysplastic syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastatic renal cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neuroendocrine carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nasopharyngeal cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
Non-Hodgkin's lymphoma stage IV
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neuroendocrine carcinoma of the skin
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal carcinoma
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
POEMS syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
2 / 2342 (0.09%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 2 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 1 |
1 / 3 |
Papillary serous endometrial carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Papillary thyroid cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Parathyroid tumour benign
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pituitary tumour benign
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Penile squamous cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
|
|
subjects affected / exposed
|
9 / 2333 (0.39%) |
11 / 2345 (0.47%) |
9 / 2342 (0.38%) |
20 / 4687 (0.43%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 11 |
0 / 9 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
4 / 2345 (0.17%) |
3 / 2342 (0.13%) |
7 / 4687 (0.15%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
Prostate cancer recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic adenoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
3 / 2345 (0.13%) |
0 / 2342 (0.00%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
1 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal cell carcinoma stage I
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal cell carcinoma stage II
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Salivary gland neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Salivary gland adenoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sarcoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Splenic marginal zone lymphoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small cell lung cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
6 / 2345 (0.26%) |
3 / 2342 (0.13%) |
9 / 4687 (0.19%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
0 / 3 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of lung
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
3 / 2345 (0.13%) |
0 / 2342 (0.00%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 3 |
Squamous cell carcinoma of skin
|
|
|
|
|
subjects affected / exposed
|
7 / 2333 (0.30%) |
4 / 2345 (0.17%) |
3 / 2342 (0.13%) |
7 / 4687 (0.15%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the oral cavity
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Thyroid neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tongue neoplasm malignant stage unspecified
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transitional cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tumour haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Uterine cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
|
Accelerated hypertension
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aneurysm
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angiopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic aneurysm
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
3 / 2345 (0.13%) |
4 / 2342 (0.17%) |
7 / 4687 (0.15%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic arteriosclerosis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic dissection
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic stenosis
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
2 / 2345 (0.09%) |
3 / 2342 (0.13%) |
5 / 4687 (0.11%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Arterial disorder
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arterial haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arterial occlusive disease
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arterial stenosis
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arteriovenous fistula
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arteritis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
3 / 2342 (0.13%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
|
|
subjects affected / exposed
|
5 / 2333 (0.21%) |
3 / 2345 (0.13%) |
10 / 2342 (0.43%) |
13 / 4687 (0.28%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
0 / 11 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic microangiopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Embolism
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Embolism arterial
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Extremity necrosis
|
|
|
|
|
subjects affected / exposed
|
5 / 2333 (0.21%) |
4 / 2345 (0.17%) |
8 / 2342 (0.34%) |
12 / 4687 (0.26%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
0 / 8 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Femoral artery embolism
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Femoral artery occlusion
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
3 / 2345 (0.13%) |
5 / 2342 (0.21%) |
8 / 4687 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 5 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertension
|
|
|
|
|
subjects affected / exposed
|
10 / 2333 (0.43%) |
4 / 2345 (0.17%) |
7 / 2342 (0.30%) |
11 / 4687 (0.23%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 4 |
0 / 7 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
|
|
subjects affected / exposed
|
8 / 2333 (0.34%) |
3 / 2345 (0.13%) |
4 / 2342 (0.17%) |
7 / 4687 (0.15%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 3 |
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypotension
|
|
|
|
|
subjects affected / exposed
|
9 / 2333 (0.39%) |
5 / 2345 (0.21%) |
4 / 2342 (0.17%) |
9 / 4687 (0.19%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
0 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypovolaemic shock
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Iliac artery occlusion
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infarction
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intermittent claudication
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
4 / 2345 (0.17%) |
5 / 2342 (0.21%) |
9 / 4687 (0.19%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemia
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Leriche syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant hypertension
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
3 / 2345 (0.13%) |
1 / 2342 (0.04%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 3 |
0 / 1 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
|
|
subjects affected / exposed
|
23 / 2333 (0.99%) |
28 / 2345 (1.19%) |
30 / 2342 (1.28%) |
58 / 4687 (1.24%) |
occurrences causally related to treatment / all
|
1 / 30 |
1 / 37 |
0 / 38 |
1 / 75 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery aneurysm
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
|
|
subjects affected / exposed
|
6 / 2333 (0.26%) |
3 / 2345 (0.13%) |
9 / 2342 (0.38%) |
12 / 4687 (0.26%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 3 |
0 / 12 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral coldness
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral embolism
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
|
|
subjects affected / exposed
|
9 / 2333 (0.39%) |
4 / 2345 (0.17%) |
11 / 2342 (0.47%) |
15 / 4687 (0.32%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 5 |
0 / 11 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral vascular disorder
|
|
|
|
|
subjects affected / exposed
|
8 / 2333 (0.34%) |
3 / 2345 (0.13%) |
6 / 2342 (0.26%) |
9 / 4687 (0.19%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 3 |
1 / 8 |
1 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral venous disease
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subclavian artery stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombophlebitis superficial
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
2 / 2345 (0.09%) |
2 / 2342 (0.09%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Varicose ulceration
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Varicose vein
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular calcification
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular insufficiency
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Venous occlusion
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Venous thrombosis limb
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
|
|
Angioplasty
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary angioplasty
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary arterial stent insertion
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery bypass
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
3 / 2345 (0.13%) |
4 / 2342 (0.17%) |
7 / 4687 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary revascularisation
|
|
|
|
|
subjects affected / exposed
|
5 / 2333 (0.21%) |
2 / 2345 (0.09%) |
4 / 2342 (0.17%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fracture treatment
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Percutaneous coronary intervention
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
3 / 2342 (0.13%) |
5 / 4687 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prophylaxis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stent placement
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
|
Adverse drug reaction
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac death
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
4 / 2345 (0.17%) |
2 / 2342 (0.09%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 2 |
0 / 6 |
Asthenia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chills
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chest pain
|
|
|
|
|
subjects affected / exposed
|
28 / 2333 (1.20%) |
32 / 2345 (1.36%) |
33 / 2342 (1.41%) |
65 / 4687 (1.39%) |
occurrences causally related to treatment / all
|
0 / 31 |
1 / 32 |
0 / 36 |
1 / 68 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chest discomfort
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
2 / 2345 (0.09%) |
3 / 2342 (0.13%) |
5 / 4687 (0.11%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Death
|
|
|
|
|
subjects affected / exposed
|
12 / 2333 (0.51%) |
10 / 2345 (0.43%) |
5 / 2342 (0.21%) |
15 / 4687 (0.32%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 10 |
0 / 5 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 12 |
0 / 10 |
0 / 5 |
0 / 15 |
Device defective
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device difficult to use
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device deposit issue
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device occlusion
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device malfunction
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dysplasia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Drug ineffective
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Drowning
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Extravasation
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fatigue
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Feeling abnormal
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Generalised oedema
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Granuloma
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hernia
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Implant site necrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Multi-organ failure
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
0 / 1 |
Malaise
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
|
|
subjects affected / exposed
|
5 / 2333 (0.21%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
|
|
subjects affected / exposed
|
6 / 2333 (0.26%) |
5 / 2345 (0.21%) |
15 / 2342 (0.64%) |
20 / 4687 (0.43%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
1 / 15 |
1 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Necrobiosis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oversensing
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pacemaker generated arrhythmia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Perforated ulcer
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pain
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral swelling
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Polyp
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
|
|
subjects affected / exposed
|
5 / 2333 (0.21%) |
7 / 2345 (0.30%) |
2 / 2342 (0.09%) |
9 / 4687 (0.19%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
0 / 2 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stent malfunction
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Strangulated hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sudden death
|
|
|
|
|
subjects affected / exposed
|
6 / 2333 (0.26%) |
8 / 2345 (0.34%) |
5 / 2342 (0.21%) |
13 / 4687 (0.28%) |
occurrences causally related to treatment / all
|
1 / 6 |
1 / 8 |
0 / 5 |
1 / 13 |
deaths causally related to treatment / all
|
1 / 6 |
1 / 8 |
0 / 5 |
1 / 13 |
Sudden cardiac death
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
2 / 2345 (0.09%) |
2 / 2342 (0.09%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 4 |
Systemic inflammatory response syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ulcer
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
|
Anaphylactic reaction
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anaphylactic shock
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Food allergy
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Contrast media allergy
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypersensitivity
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Iodine allergy
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Social circumstances
|
|
|
|
|
Physical assault
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
|
Benign prostatic hyperplasia
|
|
|
|
|
subjects affected / exposed
|
6 / 2333 (0.26%) |
8 / 2345 (0.34%) |
10 / 2342 (0.43%) |
18 / 4687 (0.38%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
1 / 11 |
1 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Cystocele
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial hyperplasia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fibrocystic breast disease
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Genital prolapse
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gynaecomastia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Menorrhagia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian cyst
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostatism
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic obstruction
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
2 / 2345 (0.09%) |
2 / 2342 (0.09%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
1 / 2 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Uterine polyp
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Uterine prolapse
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Uterovaginal prolapse
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vaginal prolapse
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
|
Acute pulmonary oedema
|
|
|
|
|
subjects affected / exposed
|
5 / 2333 (0.21%) |
7 / 2345 (0.30%) |
1 / 2342 (0.04%) |
8 / 4687 (0.17%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
0 / 1 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
Acute respiratory distress syndrome
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute respiratory failure
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
5 / 2345 (0.21%) |
3 / 2342 (0.13%) |
8 / 4687 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
Allergic sinusitis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Asthma
|
|
|
|
|
subjects affected / exposed
|
6 / 2333 (0.26%) |
4 / 2345 (0.17%) |
2 / 2342 (0.09%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atelectasis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
3 / 2342 (0.13%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial secretion retention
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis chronic
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
|
|
subjects affected / exposed
|
11 / 2333 (0.47%) |
6 / 2345 (0.26%) |
10 / 2342 (0.43%) |
16 / 4687 (0.34%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 7 |
0 / 14 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
|
|
subjects affected / exposed
|
14 / 2333 (0.60%) |
6 / 2345 (0.26%) |
9 / 2342 (0.38%) |
15 / 4687 (0.32%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 7 |
0 / 9 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea exertional
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Emphysema
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
3 / 2345 (0.13%) |
2 / 2342 (0.09%) |
5 / 4687 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemothorax
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hydrothorax
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Idiopathic pulmonary fibrosis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Laryngeal oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung infiltration
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mediastinal haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nasal polyps
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Obstructive airways disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Paranasal cyst
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
1 / 2345 (0.04%) |
4 / 2342 (0.17%) |
5 / 4687 (0.11%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
1 / 4 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pleural fibrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Pleurisy
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pleuritic pain
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonitis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Pulmonary arterial hypertension
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary congestion
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
0 / 2345 (0.00%) |
6 / 2342 (0.26%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Pulmonary fibrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
Pulmonary hypertension
|
|
|
|
|
subjects affected / exposed
|
5 / 2333 (0.21%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary mass
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
|
|
subjects affected / exposed
|
5 / 2333 (0.21%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary toxicity
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory distress
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory arrest
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
|
|
subjects affected / exposed
|
9 / 2333 (0.39%) |
2 / 2345 (0.09%) |
4 / 2342 (0.17%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 2 |
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinus disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sleep apnoea syndrome
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Status asthmaticus
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper airway obstruction
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vocal cord polyp
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vocal cord thickening
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
|
Anxiety
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Confusional state
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
3 / 2345 (0.13%) |
0 / 2342 (0.00%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 3 |
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Delirium
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Depression
|
|
|
|
|
subjects affected / exposed
|
5 / 2333 (0.21%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hallucination
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Insomnia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Major depression
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rapid eye movements sleep abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Substance abuse
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Suicidal ideation
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Suicide attempt
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Hepatobiliary disorders
|
|
|
|
|
Bile duct obstruction
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct stone
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
4 / 2345 (0.17%) |
2 / 2342 (0.09%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
1 / 2 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
4 / 2345 (0.17%) |
5 / 2342 (0.21%) |
9 / 4687 (0.19%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
7 / 2345 (0.30%) |
6 / 2342 (0.26%) |
13 / 4687 (0.28%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
0 / 6 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
|
|
subjects affected / exposed
|
7 / 2333 (0.30%) |
9 / 2345 (0.38%) |
12 / 2342 (0.51%) |
21 / 4687 (0.45%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 9 |
1 / 12 |
1 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis chronic
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gallbladder disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholestasis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic cirrhosis
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
2 / 2345 (0.09%) |
2 / 2342 (0.09%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
1 / 2 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic failure
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic steatosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic hepatitis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic function abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Non-alcoholic steatohepatitis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Jaundice cholestatic
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Portal hypertension
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post cholecystectomy syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sphincter of Oddi dysfunction
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
|
Alanine aminotransferase increased
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angiogram normal
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angiogram
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arteriogram coronary
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anticoagulation drug level above therapeutic
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood calcium decreased
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aspartate aminotransferase increased
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Biopsy lung
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood creatine phosphokinase MB increased
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood creatine phosphokinase increased
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood glucose fluctuation
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood lactate dehydrogenase increased
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood magnesium decreased
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood potassium increased
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood pressure increased
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood urea increased
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood pressure orthostatic decreased
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac murmur
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
C-reactive protein increased
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac stress test abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Catheterisation cardiac
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ejection fraction decreased
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Electrocardiogram T wave inversion
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemoglobin decreased
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
3 / 2345 (0.13%) |
0 / 2342 (0.00%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Heart rate irregular
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lipase increased
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Liver function test abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oxygen consumption increased
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Physical examination
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic specific antigen increased
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Scan myocardial perfusion abnormal
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Smear cervix abnormal
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transaminases increased
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Troponin I increased
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Troponin increased
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Weight decreased
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
White blood cell count increased
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
|
Accident at work
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acetabulum fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anaemia postoperative
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Animal bite
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
4 / 2345 (0.17%) |
2 / 2342 (0.09%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 4 |
0 / 2 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Avulsion fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Back injury
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain contusion
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chest injury
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chemical poisoning
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
Cardiac procedure complication
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clavicle fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Concussion
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
2 / 2342 (0.09%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery restenosis
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
4 / 2345 (0.17%) |
2 / 2342 (0.09%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Contusion
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
2 / 2345 (0.09%) |
2 / 2342 (0.09%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Deep vein thrombosis postoperative
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fall
|
|
|
|
|
subjects affected / exposed
|
16 / 2333 (0.69%) |
9 / 2345 (0.38%) |
16 / 2342 (0.68%) |
25 / 4687 (0.53%) |
occurrences causally related to treatment / all
|
0 / 16 |
1 / 9 |
0 / 16 |
1 / 25 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fracture displacement
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Graft thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal anastomotic complication
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Head injury
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Hand fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gun shot wound
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
7 / 2342 (0.30%) |
8 / 4687 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
3 / 2342 (0.13%) |
5 / 4687 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Injury
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intentional overdose
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal anastomosis complication
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Joint injury
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Kidney rupture
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Laceration
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ligament rupture
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ligament sprain
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Limb injury
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Multiple fractures
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Multiple injuries
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscle injury
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Open fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Overdose
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Periorbital contusion
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery restenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Periprosthetic fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Perirenal haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post laminectomy syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural discomfort
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haematuria
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
3 / 2345 (0.13%) |
0 / 2342 (0.00%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative ileus
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pubis fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
3 / 2345 (0.13%) |
0 / 2342 (0.00%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
|
|
subjects affected / exposed
|
6 / 2333 (0.26%) |
4 / 2345 (0.17%) |
4 / 2342 (0.17%) |
8 / 4687 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
|
|
subjects affected / exposed
|
6 / 2333 (0.26%) |
6 / 2345 (0.26%) |
9 / 2342 (0.38%) |
15 / 4687 (0.32%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
0 / 9 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
Scar
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Seroma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin abrasion
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal column injury
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
3 / 2342 (0.13%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stab wound
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Splenic rupture
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subdural haemorrhage
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tendon injury
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tongue injury
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
|
|
subjects affected / exposed
|
7 / 2333 (0.30%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic haematoma
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic intracranial haemorrhage
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic renal injury
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic liver injury
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ulna fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular graft occlusion
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
3 / 2342 (0.13%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular graft thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
3 / 2345 (0.13%) |
1 / 2342 (0.04%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
|
|
Atrial septal defect
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hydrocele
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Congenital anomalies of ear ossicles
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Phimosis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyloric stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
|
Acute coronary syndrome
|
|
|
|
|
subjects affected / exposed
|
10 / 2333 (0.43%) |
10 / 2345 (0.43%) |
14 / 2342 (0.60%) |
24 / 4687 (0.51%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 10 |
0 / 14 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
Acute myocardial infarction
|
|
|
|
|
subjects affected / exposed
|
42 / 2333 (1.80%) |
32 / 2345 (1.36%) |
48 / 2342 (2.05%) |
80 / 4687 (1.71%) |
occurrences causally related to treatment / all
|
2 / 46 |
2 / 33 |
2 / 56 |
4 / 89 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 3 |
0 / 6 |
0 / 9 |
Angina pectoris
|
|
|
|
|
subjects affected / exposed
|
32 / 2333 (1.37%) |
36 / 2345 (1.54%) |
42 / 2342 (1.79%) |
78 / 4687 (1.66%) |
occurrences causally related to treatment / all
|
2 / 33 |
2 / 40 |
3 / 45 |
5 / 85 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
|
|
subjects affected / exposed
|
87 / 2333 (3.73%) |
82 / 2345 (3.50%) |
73 / 2342 (3.12%) |
155 / 4687 (3.31%) |
occurrences causally related to treatment / all
|
3 / 106 |
13 / 101 |
3 / 89 |
16 / 190 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve disease
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
5 / 2345 (0.21%) |
1 / 2342 (0.04%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Arteriosclerosis coronary artery
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
6 / 2342 (0.26%) |
7 / 4687 (0.15%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
|
|
subjects affected / exposed
|
14 / 2333 (0.60%) |
25 / 2345 (1.07%) |
12 / 2342 (0.51%) |
37 / 4687 (0.79%) |
occurrences causally related to treatment / all
|
0 / 14 |
1 / 27 |
0 / 13 |
1 / 40 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
|
|
subjects affected / exposed
|
5 / 2333 (0.21%) |
7 / 2345 (0.30%) |
4 / 2342 (0.17%) |
11 / 4687 (0.23%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
0 / 4 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial tachycardia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block complete
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
2 / 2345 (0.09%) |
3 / 2342 (0.13%) |
5 / 4687 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block first degree
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bradyarrhythmia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block second degree
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
|
|
subjects affected / exposed
|
11 / 2333 (0.47%) |
2 / 2345 (0.09%) |
4 / 2342 (0.17%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
1 / 11 |
1 / 2 |
0 / 4 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bundle branch block bilateral
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bundle branch block right
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
|
|
subjects affected / exposed
|
12 / 2333 (0.51%) |
6 / 2345 (0.26%) |
5 / 2342 (0.21%) |
11 / 4687 (0.23%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 6 |
0 / 5 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 10 |
0 / 2 |
0 / 2 |
0 / 4 |
Cardiac disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac asthma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Cardiac failure
|
|
|
|
|
subjects affected / exposed
|
55 / 2333 (2.36%) |
42 / 2345 (1.79%) |
24 / 2342 (1.02%) |
66 / 4687 (1.41%) |
occurrences causally related to treatment / all
|
1 / 67 |
3 / 50 |
1 / 25 |
4 / 75 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 1 |
0 / 4 |
Cardiac failure acute
|
|
|
|
|
subjects affected / exposed
|
9 / 2333 (0.39%) |
4 / 2345 (0.17%) |
2 / 2342 (0.09%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 4 |
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
Cardiac failure chronic
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
4 / 2345 (0.17%) |
2 / 2342 (0.09%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure congestive
|
|
|
|
|
subjects affected / exposed
|
45 / 2333 (1.93%) |
30 / 2345 (1.28%) |
35 / 2342 (1.49%) |
65 / 4687 (1.39%) |
occurrences causally related to treatment / all
|
0 / 63 |
2 / 39 |
1 / 48 |
3 / 87 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 1 |
Cardiac failure high output
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
|
|
subjects affected / exposed
|
6 / 2333 (0.26%) |
5 / 2345 (0.21%) |
2 / 2342 (0.09%) |
7 / 4687 (0.15%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 4 |
0 / 2 |
0 / 6 |
Cardiogenic shock
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
2 / 2345 (0.09%) |
2 / 2342 (0.09%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
0 / 4 |
Cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiopulmonary failure
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
Cardiorenal syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiovascular insufficiency
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiovascular disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Congestive cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
|
|
subjects affected / exposed
|
46 / 2333 (1.97%) |
21 / 2345 (0.90%) |
29 / 2342 (1.24%) |
50 / 4687 (1.07%) |
occurrences causally related to treatment / all
|
0 / 48 |
0 / 26 |
1 / 33 |
1 / 59 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery insufficiency
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery occlusion
|
|
|
|
|
subjects affected / exposed
|
6 / 2333 (0.26%) |
3 / 2345 (0.13%) |
7 / 2342 (0.30%) |
10 / 4687 (0.21%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
0 / 7 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
|
|
subjects affected / exposed
|
5 / 2333 (0.21%) |
5 / 2345 (0.21%) |
5 / 2342 (0.21%) |
10 / 4687 (0.21%) |
occurrences causally related to treatment / all
|
0 / 6 |
1 / 5 |
0 / 6 |
1 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cyanosis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diastolic dysfunction
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive heart disease
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Intracardiac thrombus
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
4 / 2342 (0.17%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Left atrial dilatation
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Left ventricular dysfunction
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Left ventricular failure
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Microvascular coronary artery disease
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial ischaemia
|
|
|
|
|
subjects affected / exposed
|
15 / 2333 (0.64%) |
5 / 2345 (0.21%) |
7 / 2342 (0.30%) |
12 / 4687 (0.26%) |
occurrences causally related to treatment / all
|
0 / 16 |
1 / 5 |
0 / 7 |
1 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
|
|
subjects affected / exposed
|
47 / 2333 (2.01%) |
50 / 2345 (2.13%) |
44 / 2342 (1.88%) |
94 / 4687 (2.01%) |
occurrences causally related to treatment / all
|
3 / 48 |
8 / 55 |
1 / 48 |
9 / 103 |
deaths causally related to treatment / all
|
0 / 11 |
0 / 12 |
0 / 9 |
0 / 21 |
Nodal arrhythmia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Myocarditis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pericardial cyst
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Palpitations
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Papillary muscle disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Right ventricular failure
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Postinfarction angina
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Silent myocardial infarction
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
3 / 2345 (0.13%) |
3 / 2342 (0.13%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 3 |
1 / 3 |
3 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinus arrhythmia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
5 / 2345 (0.21%) |
1 / 2342 (0.04%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinus node dysfunction
|
|
|
|
|
subjects affected / exposed
|
6 / 2333 (0.26%) |
5 / 2345 (0.21%) |
3 / 2342 (0.13%) |
8 / 4687 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
|
|
subjects affected / exposed
|
5 / 2333 (0.21%) |
3 / 2345 (0.13%) |
0 / 2342 (0.00%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Systolic dysfunction
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tachycardia paroxysmal
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Trifascicular block
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular extrasystoles
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular arrhythmia
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular fibrillation
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Ventricular tachycardia
|
|
|
|
|
subjects affected / exposed
|
8 / 2333 (0.34%) |
2 / 2345 (0.09%) |
5 / 2342 (0.21%) |
7 / 4687 (0.15%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 2 |
1 / 5 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
|
|
Altered state of consciousness
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aphasia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Amnesia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Balance disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Autonomic neuropathy
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain stem haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Brain stem infarction
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain stem ischaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain stem stroke
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carotid arteriosclerosis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery occlusion
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
4 / 2342 (0.17%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery disease
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
|
|
subjects affected / exposed
|
10 / 2333 (0.43%) |
7 / 2345 (0.30%) |
12 / 2342 (0.51%) |
19 / 4687 (0.41%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 7 |
0 / 12 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Central nervous system inflammation
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebellar infarction
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
2 / 2345 (0.09%) |
2 / 2342 (0.09%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral arteriosclerosis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral artery occlusion
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral artery stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral ataxia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral infarction
|
|
|
|
|
subjects affected / exposed
|
7 / 2333 (0.30%) |
7 / 2345 (0.30%) |
11 / 2342 (0.47%) |
18 / 4687 (0.38%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
1 / 11 |
1 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral ischaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
3 / 2345 (0.13%) |
1 / 2342 (0.04%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
|
|
subjects affected / exposed
|
31 / 2333 (1.33%) |
46 / 2345 (1.96%) |
37 / 2342 (1.58%) |
83 / 4687 (1.77%) |
occurrences causally related to treatment / all
|
1 / 34 |
0 / 47 |
0 / 39 |
0 / 86 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
0 / 5 |
Cerebrovascular disorder
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Cerebrovascular insufficiency
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervical cord compression
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervical myelopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervical radiculopathy
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cognitive disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Complex partial seizures
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coordination abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dementia Alzheimer's type
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Diabetic neuropathy
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dizziness
|
|
|
|
|
subjects affected / exposed
|
5 / 2333 (0.21%) |
8 / 2345 (0.34%) |
5 / 2342 (0.21%) |
13 / 4687 (0.28%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 8 |
0 / 5 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dysarthria
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Embolic cerebral infarction
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Embolic stroke
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
2 / 2342 (0.09%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Generalised tonic-clonic seizure
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Guillain-Barre syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic cerebral infarction
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic stroke
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
Headache
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hemiplegia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hydrocephalus
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypercapnic coma
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperkinesia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive encephalopathy
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoaesthesia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemic coma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypotonia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
IIIrd nerve paralysis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intercostal neuralgia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic cerebral infarction
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
|
|
subjects affected / exposed
|
22 / 2333 (0.94%) |
18 / 2345 (0.77%) |
20 / 2342 (0.85%) |
38 / 4687 (0.81%) |
occurrences causally related to treatment / all
|
1 / 26 |
1 / 18 |
1 / 24 |
2 / 42 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
0 / 4 |
Lacunar infarction
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Leukoencephalopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar radiculopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Migraine
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mononeuritis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Monoplegia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscle spasticity
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myelitis transverse
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myelopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myoclonus
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nerve root compression
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neuroleptic malignant syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Paraesthesia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Paraplegia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Paraparesis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Parkinson's disease
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Partial seizures
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral motor neuropathy
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peroneal nerve palsy
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Petit mal epilepsy
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Piriformis syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Presyncope
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Radiculopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sciatica
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Seizure
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
7 / 2345 (0.30%) |
5 / 2342 (0.21%) |
12 / 4687 (0.26%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 9 |
0 / 7 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sensory disturbance
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal cord compression
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal epidural haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
3 / 2345 (0.13%) |
2 / 2342 (0.09%) |
5 / 4687 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Spondylitic myelopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Syncope
|
|
|
|
|
subjects affected / exposed
|
8 / 2333 (0.34%) |
9 / 2345 (0.38%) |
18 / 2342 (0.77%) |
27 / 4687 (0.58%) |
occurrences causally related to treatment / all
|
0 / 8 |
2 / 9 |
1 / 19 |
3 / 28 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subdural hygroma
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thalamic infarction
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombotic cerebral infarction
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombotic stroke
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Transient ischaemic attack
|
|
|
|
|
subjects affected / exposed
|
23 / 2333 (0.99%) |
23 / 2345 (0.98%) |
30 / 2342 (1.28%) |
53 / 4687 (1.13%) |
occurrences causally related to treatment / all
|
1 / 26 |
0 / 24 |
0 / 30 |
0 / 54 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
VIIth nerve paralysis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular encephalopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vertebral artery dissection
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vertebral artery stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vertebrobasilar insufficiency
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vocal cord paresis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
|
Anaemia
|
|
|
|
|
subjects affected / exposed
|
12 / 2333 (0.51%) |
8 / 2345 (0.34%) |
7 / 2342 (0.30%) |
15 / 4687 (0.32%) |
occurrences causally related to treatment / all
|
1 / 12 |
0 / 8 |
0 / 7 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coagulopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Febrile neutropenia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic anaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypereosinophilic syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypochromic anaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypocoagulable state
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Iron deficiency anaemia
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
4 / 2342 (0.17%) |
5 / 4687 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Microcytic anaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Normochromic normocytic anaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
|
|
Deafness
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerumen impaction
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Deafness unilateral
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sudden hearing loss
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tinnitus
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tympanic membrane perforation
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo
|
|
|
|
|
subjects affected / exposed
|
7 / 2333 (0.30%) |
2 / 2345 (0.09%) |
9 / 2342 (0.38%) |
11 / 4687 (0.23%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 2 |
0 / 10 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
|
|
subjects affected / exposed
|
6 / 2333 (0.26%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
|
Amaurosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blindness
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blindness unilateral
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cataract
|
|
|
|
|
subjects affected / exposed
|
9 / 2333 (0.39%) |
13 / 2345 (0.55%) |
11 / 2342 (0.47%) |
24 / 4687 (0.51%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 16 |
0 / 13 |
0 / 29 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cataract cortical
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Corneal degeneration
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic retinopathy
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Exfoliation syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Glaucoma
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
3 / 2345 (0.13%) |
2 / 2342 (0.09%) |
5 / 4687 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Keratopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Macular fibrosis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Macular oedema
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Papilloedema
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retinal artery occlusion
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 3 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
4 / 2345 (0.17%) |
2 / 2342 (0.09%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retinal tear
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retinoschisis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retinopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Visual acuity reduced
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vitreous haemorrhage
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
1 / 2345 (0.04%) |
3 / 2342 (0.13%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vitreous opacities
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
3 / 2345 (0.13%) |
0 / 2342 (0.00%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
|
Abdominal hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
2 / 2342 (0.09%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
|
|
subjects affected / exposed
|
5 / 2333 (0.21%) |
5 / 2345 (0.21%) |
2 / 2342 (0.09%) |
7 / 4687 (0.15%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal hernia obstructive
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain lower
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
3 / 2345 (0.13%) |
2 / 2342 (0.09%) |
5 / 4687 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anal fissure
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anal fistula
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ascites
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bezoar
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic gastritis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
3 / 2342 (0.13%) |
5 / 4687 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colon dysplasia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Constipation
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
2 / 2345 (0.09%) |
2 / 2342 (0.09%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Crohn's disease
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dental caries
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic gastroparesis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic gastropathy
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
|
|
subjects affected / exposed
|
6 / 2333 (0.26%) |
6 / 2345 (0.26%) |
4 / 2342 (0.17%) |
10 / 4687 (0.21%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
0 / 5 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum intestinal
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
3 / 2345 (0.13%) |
1 / 2342 (0.04%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer perforation
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Duodenitis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enteritis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enterocolitis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Erosive duodenitis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epigastric discomfort
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Food poisoning
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Faecaloma
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric polyps
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
2 / 2345 (0.09%) |
7 / 2342 (0.30%) |
9 / 4687 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis haemorrhagic
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroduodenal ulcer
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal angiodysplasia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroduodenitis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
9 / 2333 (0.39%) |
4 / 2345 (0.17%) |
4 / 2342 (0.17%) |
8 / 4687 (0.17%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 4 |
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
|
|
subjects affected / exposed
|
5 / 2333 (0.21%) |
7 / 2345 (0.30%) |
3 / 2342 (0.13%) |
10 / 4687 (0.21%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
0 / 3 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gingival bleeding
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal inflammation
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematochezia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoids thrombosed
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ileus
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ileus paralytic
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Impaired gastric emptying
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
3 / 2342 (0.13%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated umbilical hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
5 / 2345 (0.21%) |
4 / 2342 (0.17%) |
9 / 4687 (0.19%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia strangulated
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal ischaemia
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Intestinal obstruction
|
|
|
|
|
subjects affected / exposed
|
5 / 2333 (0.21%) |
1 / 2345 (0.04%) |
3 / 2342 (0.13%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Irritable bowel syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Large intestinal ulcer
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
5 / 2345 (0.21%) |
0 / 2342 (0.00%) |
5 / 4687 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Localised intraabdominal fluid collection
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mallory-Weiss syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Melaena
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nausea
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
4 / 2345 (0.17%) |
2 / 2342 (0.09%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mesenteric vein thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
3 / 2345 (0.13%) |
3 / 2342 (0.13%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 6 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
1 / 2345 (0.04%) |
3 / 2342 (0.13%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
2 / 3 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis chronic
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis relapsing
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peptic ulcer
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peptic ulcer haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peptic ulcer perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peritoneal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Rectal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
2 / 2345 (0.09%) |
2 / 2342 (0.09%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
3 / 2345 (0.13%) |
2 / 2342 (0.09%) |
5 / 4687 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stomatitis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small intestinal perforation
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subileus
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stress ulcer
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
2 / 2345 (0.09%) |
5 / 2342 (0.21%) |
7 / 4687 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
3 / 2345 (0.13%) |
0 / 2342 (0.00%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombosis mesenteric vessel
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Varices oesophageal
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Volvulus
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vomiting
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
3 / 2345 (0.13%) |
4 / 2342 (0.17%) |
7 / 4687 (0.15%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
|
Angioedema
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
3 / 2342 (0.13%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cold sweat
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dermal cyst
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dermatitis contact
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic bullosis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic foot
|
|
|
|
|
subjects affected / exposed
|
12 / 2333 (0.51%) |
10 / 2345 (0.43%) |
11 / 2342 (0.47%) |
21 / 4687 (0.45%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 10 |
0 / 14 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eczema
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Erythema
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Erythrodermic psoriasis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ingrowing nail
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Leukoplakia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neuropathic ulcer
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pemphigus
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin fibrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin necrosis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
|
|
subjects affected / exposed
|
10 / 2333 (0.43%) |
6 / 2345 (0.26%) |
11 / 2342 (0.47%) |
17 / 4687 (0.36%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 7 |
0 / 12 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Skin ulcer haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urticaria
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
|
Acute kidney injury
|
|
|
|
|
subjects affected / exposed
|
32 / 2333 (1.37%) |
26 / 2345 (1.11%) |
19 / 2342 (0.81%) |
45 / 4687 (0.96%) |
occurrences causally related to treatment / all
|
3 / 34 |
0 / 27 |
4 / 19 |
4 / 46 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute prerenal failure
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Albuminuria
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder neck sclerosis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anuria
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder outlet obstruction
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Calculus bladder
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Calculus ureteric
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Calculus urinary
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis glandularis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
2 / 2345 (0.09%) |
4 / 2342 (0.17%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis haemorrhagic
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic nephropathy
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
2 / 2345 (0.09%) |
2 / 2342 (0.09%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dysuria
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematuria
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive nephropathy
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Lower urinary tract symptoms
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Microalbuminuria
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nephritis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
3 / 2345 (0.13%) |
7 / 2342 (0.30%) |
10 / 4687 (0.21%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 7 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nephropathy
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nephrotic syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Obstructive uropathy
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oliguria
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Polyuria
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal artery arteriosclerosis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal artery stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal colic
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal cyst
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
2 / 2345 (0.09%) |
4 / 2342 (0.17%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal failure
|
|
|
|
|
subjects affected / exposed
|
10 / 2333 (0.43%) |
2 / 2345 (0.09%) |
4 / 2342 (0.17%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 2 |
1 / 4 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Renal tubular necrosis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal infarct
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stress urinary incontinence
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tubulointerstitial nephritis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ureteric obstruction
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
4 / 2345 (0.17%) |
0 / 2342 (0.00%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary bladder haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary bladder polyp
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary incontinence
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
4 / 2345 (0.17%) |
5 / 2342 (0.21%) |
9 / 4687 (0.19%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
1 / 5 |
1 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
|
|
Basedow's disease
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Goitre
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperparathyroidism
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperparathyroidism primary
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperthyroidism
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
|
Arthralgia
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
1 / 2345 (0.04%) |
5 / 2342 (0.21%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Back pain
|
|
|
|
|
subjects affected / exposed
|
9 / 2333 (0.39%) |
3 / 2345 (0.13%) |
8 / 2342 (0.34%) |
11 / 4687 (0.23%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 3 |
0 / 8 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bursitis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bone fistula
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervical spinal stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Costochondritis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dupuytren's contracture
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dactylitis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Foot deformity
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Flank pain
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fistula
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fracture nonunion
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fracture delayed union
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gouty arthritis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gouty tophus
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc compression
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc degeneration
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
|
|
subjects affected / exposed
|
10 / 2333 (0.43%) |
4 / 2345 (0.17%) |
6 / 2342 (0.26%) |
10 / 4687 (0.21%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 4 |
0 / 6 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
3 / 2342 (0.13%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower extremity mass
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscle tightness
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscle twitching
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
2 / 2345 (0.09%) |
3 / 2342 (0.13%) |
5 / 4687 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myofascial pain syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myalgia
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myositis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neck pain
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neuropathic arthropathy
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteitis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteitis deformans
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
|
|
subjects affected / exposed
|
15 / 2333 (0.64%) |
15 / 2345 (0.64%) |
17 / 2342 (0.73%) |
32 / 4687 (0.68%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 16 |
0 / 18 |
0 / 34 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteomalacia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteoporosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteoporotic fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
3 / 2345 (0.13%) |
6 / 2342 (0.26%) |
9 / 4687 (0.19%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
0 / 6 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pathological fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Periarthritis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
3 / 2342 (0.13%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
5 / 2342 (0.21%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
1 / 5 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
6 / 2345 (0.26%) |
1 / 2342 (0.04%) |
7 / 4687 (0.15%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 1 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal column stenosis
|
|
|
|
|
subjects affected / exposed
|
6 / 2333 (0.26%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal pain
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spondylitis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Synovitis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tendonitis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tenosynovitis stenosans
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Trigger finger
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
|
Abdominal abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal wall abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
6 / 2345 (0.26%) |
2 / 2342 (0.09%) |
8 / 4687 (0.17%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
0 / 2 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abscess of eyelid
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute sinusitis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Amoebiasis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Amoebic dysentery
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
5 / 2345 (0.21%) |
3 / 2342 (0.13%) |
8 / 4687 (0.17%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis perforated
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerotic gangrene
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atypical pneumonia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
3 / 2342 (0.13%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bacterial sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Biliary tract infection
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bone abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchiolitis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
|
|
subjects affected / exposed
|
10 / 2333 (0.43%) |
5 / 2345 (0.21%) |
5 / 2342 (0.21%) |
10 / 4687 (0.21%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 5 |
0 / 5 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis viral
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchopneumonia
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
1 / 2345 (0.04%) |
3 / 2342 (0.13%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Catheter site infection
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
|
subjects affected / exposed
|
20 / 2333 (0.86%) |
11 / 2345 (0.47%) |
17 / 2342 (0.73%) |
28 / 4687 (0.60%) |
occurrences causally related to treatment / all
|
0 / 24 |
0 / 20 |
0 / 17 |
0 / 37 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis gangrenous
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis of male external genital organ
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis staphylococcal
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis infective
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic sinusitis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
3 / 2342 (0.13%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cutaneous larva migrans
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis bacterial
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dengue fever
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device related infection
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic foot infection
|
|
|
|
|
subjects affected / exposed
|
6 / 2333 (0.26%) |
5 / 2345 (0.21%) |
7 / 2342 (0.30%) |
12 / 4687 (0.26%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
0 / 8 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device related sepsis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
3 / 2345 (0.13%) |
0 / 2342 (0.00%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic gangrene
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eczema infected
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ear infection
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Empyema
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enterocolitis infectious
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enterocolitis viral
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endophthalmitis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epididymitis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
|
|
subjects affected / exposed
|
9 / 2333 (0.39%) |
8 / 2345 (0.34%) |
5 / 2342 (0.21%) |
13 / 4687 (0.28%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 8 |
0 / 5 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Furuncle
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Febrile infection
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
|
|
subjects affected / exposed
|
15 / 2333 (0.64%) |
18 / 2345 (0.77%) |
15 / 2342 (0.64%) |
33 / 4687 (0.70%) |
occurrences causally related to treatment / all
|
0 / 16 |
1 / 18 |
2 / 17 |
3 / 35 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gallbladder empyema
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gangrene
|
|
|
|
|
subjects affected / exposed
|
8 / 2333 (0.34%) |
10 / 2345 (0.43%) |
6 / 2342 (0.26%) |
16 / 4687 (0.34%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 13 |
0 / 6 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis salmonella
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal infection
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal protozoal infection
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Giardiasis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
H1N1 influenza
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infected skin ulcer
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
2 / 2345 (0.09%) |
3 / 2342 (0.13%) |
5 / 4687 (0.11%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Infectious colitis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Incision site infection
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infectious pleural effusion
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Influenza
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia gangrenous
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infusion site infection
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal fistula infection
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal tuberculosis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Kidney infection
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Klebsiella infection
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Labyrinthitis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Liver abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lobar pneumonia
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Localised infection
|
|
|
|
|
subjects affected / exposed
|
5 / 2333 (0.21%) |
2 / 2345 (0.09%) |
4 / 2342 (0.17%) |
6 / 4687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
4 / 2333 (0.17%) |
8 / 2345 (0.34%) |
2 / 2342 (0.09%) |
10 / 4687 (0.21%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
0 / 2 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower respiratory tract infection bacterial
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung infection
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lyme disease
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mediastinitis
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningitis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningitis bacterial
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningitis streptococcal
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningitis tuberculous
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscle abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myelitis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nasal abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal candidiasis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis acute
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
|
|
subjects affected / exposed
|
5 / 2333 (0.21%) |
5 / 2345 (0.21%) |
9 / 2342 (0.38%) |
14 / 4687 (0.30%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
0 / 9 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis bacterial
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis chronic
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Otitis externa
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Otitis media
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
2 / 2345 (0.09%) |
3 / 2342 (0.13%) |
5 / 4687 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Periodontitis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peritonsillar abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pertussis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pharyngotonsillitis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
|
|
subjects affected / exposed
|
53 / 2333 (2.27%) |
41 / 2345 (1.75%) |
38 / 2342 (1.62%) |
79 / 4687 (1.69%) |
occurrences causally related to treatment / all
|
0 / 63 |
0 / 45 |
0 / 41 |
0 / 86 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 3 |
0 / 6 |
Pneumonia bacterial
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia fungal
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia influenzal
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia haemophilus
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia pneumococcal
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural infection
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Pseudomonal sepsis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary mycosis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psoas abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary tuberculosis
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
|
|
subjects affected / exposed
|
6 / 2333 (0.26%) |
4 / 2345 (0.17%) |
1 / 2342 (0.04%) |
5 / 4687 (0.11%) |
occurrences causally related to treatment / all
|
1 / 6 |
1 / 4 |
1 / 1 |
2 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
5 / 2342 (0.21%) |
5 / 4687 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
1 / 5 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
7 / 2333 (0.30%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis chronic
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Salmonellosis
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rotavirus infection
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rhinitis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sepsis
|
|
|
|
|
subjects affected / exposed
|
5 / 2333 (0.21%) |
7 / 2345 (0.30%) |
6 / 2342 (0.26%) |
13 / 4687 (0.28%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
1 / 6 |
1 / 13 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 1 |
0 / 4 |
Scrotal abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Septic encephalopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Septic shock
|
|
|
|
|
subjects affected / exposed
|
8 / 2333 (0.34%) |
2 / 2345 (0.09%) |
5 / 2342 (0.21%) |
7 / 4687 (0.15%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 2 |
1 / 5 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 2 |
1 / 1 |
1 / 3 |
Sinusitis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin infection
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal skin infection
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal infection
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subcutaneous abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tonsillitis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tuberculosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tracheobronchitis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
2 / 2345 (0.09%) |
0 / 2342 (0.00%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tuberculous pleurisy
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
1 / 2345 (0.04%) |
2 / 2342 (0.09%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection pseudomonal
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
|
|
subjects affected / exposed
|
16 / 2333 (0.69%) |
13 / 2345 (0.55%) |
16 / 2342 (0.68%) |
29 / 4687 (0.62%) |
occurrences causally related to treatment / all
|
4 / 16 |
6 / 14 |
3 / 16 |
9 / 30 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection fungal
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
3 / 2342 (0.13%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
6 / 2345 (0.26%) |
11 / 2342 (0.47%) |
17 / 4687 (0.36%) |
occurrences causally related to treatment / all
|
0 / 3 |
2 / 6 |
4 / 12 |
6 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
2 / 2 |
Vaginal cellulitis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vestibular neuronitis
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Varicella
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Viral infection
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
2 / 2345 (0.09%) |
5 / 2342 (0.21%) |
7 / 4687 (0.15%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound infection
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
4 / 2345 (0.17%) |
3 / 2342 (0.13%) |
7 / 4687 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
|
Decreased appetite
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
1 / 2342 (0.04%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dehydration
|
|
|
|
|
subjects affected / exposed
|
5 / 2333 (0.21%) |
5 / 2345 (0.21%) |
5 / 2342 (0.21%) |
10 / 4687 (0.21%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 5 |
1 / 6 |
2 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
|
|
subjects affected / exposed
|
6 / 2333 (0.26%) |
3 / 2345 (0.13%) |
2 / 2342 (0.09%) |
5 / 4687 (0.11%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Diabetes mellitus inadequate control
|
|
|
|
|
subjects affected / exposed
|
6 / 2333 (0.26%) |
8 / 2345 (0.34%) |
3 / 2342 (0.13%) |
11 / 4687 (0.23%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
0 / 3 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic complication
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
3 / 2345 (0.13%) |
1 / 2342 (0.04%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic metabolic decompensation
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fluid overload
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gout
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
|
|
subjects affected / exposed
|
14 / 2333 (0.60%) |
5 / 2345 (0.21%) |
3 / 2342 (0.13%) |
8 / 4687 (0.17%) |
occurrences causally related to treatment / all
|
1 / 15 |
0 / 5 |
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
|
|
subjects affected / exposed
|
5 / 2333 (0.21%) |
2 / 2345 (0.09%) |
3 / 2342 (0.13%) |
5 / 4687 (0.11%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 2 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypernatraemia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypervolaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Hypoglycaemia
|
|
|
|
|
subjects affected / exposed
|
17 / 2333 (0.73%) |
10 / 2345 (0.43%) |
9 / 2342 (0.38%) |
19 / 4687 (0.41%) |
occurrences causally related to treatment / all
|
0 / 21 |
4 / 11 |
2 / 9 |
6 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypomagnesaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
2 / 2345 (0.09%) |
2 / 2342 (0.09%) |
4 / 4687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Insulin resistance
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
0 / 2342 (0.00%) |
0 / 4687 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lactic acidosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
1 / 2345 (0.04%) |
0 / 2342 (0.00%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metabolic acidosis
|
|
|
|
|
subjects affected / exposed
|
1 / 2333 (0.04%) |
0 / 2345 (0.00%) |
2 / 2342 (0.09%) |
2 / 4687 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lipomatosis
|
|
|
|
|
subjects affected / exposed
|
0 / 2333 (0.00%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Obesity
|
|
|
|
|
subjects affected / exposed
|
3 / 2333 (0.13%) |
2 / 2345 (0.09%) |
1 / 2342 (0.04%) |
3 / 4687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
|
|
subjects affected / exposed
|
2 / 2333 (0.09%) |
0 / 2345 (0.00%) |
1 / 2342 (0.04%) |
1 / 4687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |