Serious adverse events
|
Placebo |
Darapladib |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
3448 / 7890 (43.70%) |
3369 / 7912 (42.58%) |
number of deaths (all causes)
|
577 |
582 |
number of deaths resulting from adverse events
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Acoustic neuroma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute lymphocytic leukaemia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Acute myeloid leukaemia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 5 |
Adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Adenocarcinoma gastric
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
10 / 7912 (0.13%) |
occurrences causally related to treatment / all
|
1 / 4 |
4 / 11 |
deaths causally related to treatment / all
|
0 / 1 |
1 / 1 |
Adenocarcinoma pancreas
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Adenoid cystic carcinoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenoma benign
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenocortical carcinoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ameloblastoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaplastic astrocytoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angiosarcoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
B-cell lymphoma
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Basal cell carcinoma
|
|
|
subjects affected / exposed
|
8 / 7890 (0.10%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign anorectal neoplasm
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign breast neoplasm
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign hepatic neoplasm
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign lung neoplasm
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of bladder
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of thyroid gland
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign ovarian tumour
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign salivary gland neoplasm
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct adenocarcinoma
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct cancer
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 2 |
Bladder cancer
|
|
|
subjects affected / exposed
|
19 / 7890 (0.24%) |
21 / 7912 (0.27%) |
occurrences causally related to treatment / all
|
1 / 20 |
1 / 25 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Bladder cancer recurrent
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neoplasm
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder papilloma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone cancer
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Bone cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Bowen’s disease
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain neoplasm
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Brain neoplasm benign
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Brain neoplasm malignant
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
9 / 7912 (0.11%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer stage I
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast neoplasm
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchial carcinoma
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Cancer pain
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carcinoid tumour of the duodenum
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carcinoid tumour of the gastrointestinal tract
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac myxoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervix carcinoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangiocarcinoma
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Cholesteatoma
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondrosarcoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic leukaemia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic lymphocytic leukaemia
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Chronic lymphocytic leukaemia stage 0
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic myeloid leukaemia
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clear cell renal cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon adenoma
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
subjects affected / exposed
|
32 / 7890 (0.41%) |
21 / 7912 (0.27%) |
occurrences causally related to treatment / all
|
0 / 33 |
1 / 22 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 6 |
Colon cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Colon cancer stage 0
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer stage II
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal cancer
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diffuse large B-cell lymphoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Endometrial adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Endometrial cancer
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gallbladder cancer
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Gastric adenoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric cancer
|
|
|
subjects affected / exposed
|
10 / 7890 (0.13%) |
10 / 7912 (0.13%) |
occurrences causally related to treatment / all
|
2 / 10 |
0 / 10 |
deaths causally related to treatment / all
|
1 / 6 |
0 / 6 |
Gastric cancer recurrent
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal carcinoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gastrointestinal stromal cancer
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal tract adenoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glioblastoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Glioma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Glottis carcinoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemangioma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cancer
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
7 / 7912 (0.09%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 3 |
Hepatic cancer metastatic
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Hepatic neoplasm
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hepatocellular carcinoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Hypopharyngeal cancer
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypopharyngeal cancer recurrent
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraductal papillary-mucinous carcinoma of pancreas
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive ductal breast carcinoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive lobular breast carcinoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine benign neoplasm
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal cancer
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
8 / 7912 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Laryngeal cancer recurrent
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leiomyosarcoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lentigo maligna
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukaemia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lip and/or oral cavity cancer
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lip neoplasm malignant stage unspecified
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lipoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
2 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 3 |
Lung adenocarcinoma metastatic
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung adenocarcinoma stage II
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma stage IV
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung cancer metastatic
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 4 |
Lung carcinoma cell type unspecified recurrent
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lung carcinoma cell type unspecified stage III
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung neoplasm
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung neoplasm malignant
|
|
|
subjects affected / exposed
|
37 / 7890 (0.47%) |
33 / 7912 (0.42%) |
occurrences causally related to treatment / all
|
0 / 38 |
0 / 33 |
deaths causally related to treatment / all
|
0 / 19 |
0 / 19 |
Lung squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphangiosis carcinomatosa
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lymphocytic lymphoma
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphoma
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Malignant melanoma
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
9 / 7912 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Malignant melanoma in situ
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant neoplasm of ampulla of Vater
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant neoplasm of unknown primary site
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Malignant palate neoplasm
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant peritoneal neoplasm
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Mantle cell lymphoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Mediastinum neoplasm
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Meningioma
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningioma benign
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesothelioma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to abdominal cavity
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Metastases to adrenals
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Metastases to biliary tract
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastases to bone
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 4 |
Metastases to central nervous system
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Metastases to liver
|
|
|
subjects affected / exposed
|
9 / 7890 (0.11%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 3 |
Metastases to lung
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 1 |
Metastases to lymph nodes
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 3 |
Metastases to peritoneum
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastases to pleura
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastases to spine
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Metastases to the mediastinum
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Metastatic bronchial carcinoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastatic carcinoma of the bladder
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastatic lymphoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastatic malignant melanoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
Metastatic neoplasm
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Metastatic salivary gland cancer
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Morton’s neuroma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelodysplastic syndrome
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Neoplasm malignant
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Neoplasm prostate
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurilemmoma benign
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroendocrine carcinoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-Hodgkin’s lymphoma
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-small cell lung cancer
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 4 |
Non-small cell lung cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Oesophageal adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
Oesophageal carcinoma
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 3 |
Optic nerve neoplasm
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cancer
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pancreatic carcinoma
|
|
|
subjects affected / exposed
|
8 / 7890 (0.10%) |
17 / 7912 (0.21%) |
occurrences causally related to treatment / all
|
2 / 8 |
0 / 17 |
deaths causally related to treatment / all
|
2 / 6 |
0 / 11 |
Pancreatic carcinoma metastatic
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papillary thyroid cancer
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papilloma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parathyroid tumour benign
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Penile cancer
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal carcinoma metastatic
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Phaeochromocytoma malignant
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pituitary tumour benign
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Pleural mesothelioma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Polycythaemia vera
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
subjects affected / exposed
|
64 / 7890 (0.81%) |
67 / 7912 (0.85%) |
occurrences causally related to treatment / all
|
1 / 64 |
1 / 67 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 4 |
Prostate cancer metastatic
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
Prostate cancer recurrent
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic adenoma
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Rectal cancer
|
|
|
subjects affected / exposed
|
10 / 7890 (0.13%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Rectosigmoid cancer
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Renal cancer
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
8 / 7912 (0.10%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Renal cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Renal cell carcinoma
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Renal neoplasm
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Salivary gland adenoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland neoplasm
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sarcoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Signet-ring cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin cancer
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small cell lung cancer
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 2 |
Small cell lung cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Small intestine adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Soft tissue cancer
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of lung
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the oral cavity
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the tongue
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Testicular malignant teratoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Throat cancer
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Thymoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid adenoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsil cancer
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transitional cell cancer of the renal pelvis and ureter
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transitional cell carcinoma
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tumour haemorrhage
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tumour invasion
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteral neoplasm
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ureteric cancer
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary bladder adenoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract neoplasm
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine cancer
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Partial seizures with secondary generalisation
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Accelerated hypertension
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aneurysm
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aneurysm ruptured
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Angiopathy
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic aneurysm
|
|
|
subjects affected / exposed
|
24 / 7890 (0.30%) |
35 / 7912 (0.44%) |
occurrences causally related to treatment / all
|
0 / 25 |
0 / 38 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Aortic aneurysm rupture
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
Aortic arteriosclerosis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic calcification
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic dilatation
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic dissection
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Aortic stenosis
|
|
|
subjects affected / exposed
|
15 / 7890 (0.19%) |
16 / 7912 (0.20%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Aortic thrombosis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial disorder
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial insufficiency
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial occlusive disease
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial rupture
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial stenosis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
7 / 7912 (0.09%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
Arteriovenous fistula
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Artery dissection
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bleeding varicose vein
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure fluctuation
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
subjects affected / exposed
|
10 / 7890 (0.13%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
17 / 7890 (0.22%) |
10 / 7912 (0.13%) |
occurrences causally related to treatment / all
|
1 / 17 |
2 / 10 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Diabetic vascular disorder
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Embolism
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism venous
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extravasation blood
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extremity necrosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Femoral artery aneurysm
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral artery occlusion
|
|
|
subjects affected / exposed
|
12 / 7890 (0.15%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematocoele
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma
|
|
|
subjects affected / exposed
|
13 / 7890 (0.16%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Haemorrhage
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Hypertension
|
|
|
subjects affected / exposed
|
32 / 7890 (0.41%) |
29 / 7912 (0.37%) |
occurrences causally related to treatment / all
|
3 / 34 |
0 / 33 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
subjects affected / exposed
|
16 / 7890 (0.20%) |
15 / 7912 (0.19%) |
occurrences causally related to treatment / all
|
1 / 16 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoperfusion
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotension
|
|
|
subjects affected / exposed
|
39 / 7890 (0.49%) |
27 / 7912 (0.34%) |
occurrences causally related to treatment / all
|
0 / 41 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Hypovolaemic shock
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 5 |
Iliac artery occlusion
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iliac artery rupture
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infarction
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Intermittent claudication
|
|
|
subjects affected / exposed
|
28 / 7890 (0.35%) |
21 / 7912 (0.27%) |
occurrences causally related to treatment / all
|
0 / 35 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intra-abdominal haematoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemia
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic limb pain
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphocele
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic hypertension
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
subjects affected / exposed
|
8 / 7890 (0.10%) |
7 / 7912 (0.09%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic venous thrombosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
subjects affected / exposed
|
55 / 7890 (0.70%) |
46 / 7912 (0.58%) |
occurrences causally related to treatment / all
|
1 / 68 |
0 / 54 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery aneurysm
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
subjects affected / exposed
|
21 / 7890 (0.27%) |
23 / 7912 (0.29%) |
occurrences causally related to treatment / all
|
0 / 34 |
0 / 27 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Peripheral embolism
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
subjects affected / exposed
|
20 / 7890 (0.25%) |
19 / 7912 (0.24%) |
occurrences causally related to treatment / all
|
0 / 26 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Peripheral vascular disorder
|
|
|
subjects affected / exposed
|
27 / 7890 (0.34%) |
24 / 7912 (0.30%) |
occurrences causally related to treatment / all
|
0 / 29 |
0 / 32 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Phlebitis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phlebitis superficial
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Poor peripheral circulation
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Raynaud’s phenomenon
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renovascular hypertension
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shock
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shock haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Subclavian artery aneurysm
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian artery occlusion
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian artery stenosis
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian steal syndrome
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Temporal arteritis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thromboangiitis obliterans
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis superficial
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
7 / 7912 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose ulceration
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose vein
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose vein ruptured
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular insufficiency
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous insufficiency
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous stenosis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis limb
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
Coronary revascularisation
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
Adverse drug reaction
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthenia
|
|
|
subjects affected / exposed
|
15 / 7890 (0.19%) |
11 / 7912 (0.14%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Axillary pain
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac complication associated with device
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest discomfort
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
9 / 7912 (0.11%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest pain
|
|
|
subjects affected / exposed
|
18 / 7890 (0.23%) |
11 / 7912 (0.14%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Chills
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Death
|
|
|
subjects affected / exposed
|
73 / 7890 (0.93%) |
56 / 7912 (0.71%) |
occurrences causally related to treatment / all
|
1 / 73 |
0 / 56 |
deaths causally related to treatment / all
|
1 / 73 |
0 / 56 |
Device battery issue
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device dislocation
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device lead damage
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device lead issue
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device malfunction
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device occlusion
|
|
|
subjects affected / exposed
|
11 / 7890 (0.14%) |
12 / 7912 (0.15%) |
occurrences causally related to treatment / all
|
1 / 11 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device power source issue
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drowning
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Drug intolerance
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Exercise tolerance decreased
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Face oedema
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fat necrosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fatigue
|
|
|
subjects affected / exposed
|
9 / 7890 (0.11%) |
8 / 7912 (0.10%) |
occurrences causally related to treatment / all
|
1 / 10 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised oedema
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hernia
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypothermia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ill-defined disorder
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implant site thrombosis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inflammation
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza like illness
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic ulcer
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lipogranuloma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malaise
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device complication
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device pain
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device site reaction
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multi-organ disorder
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Multi-organ failure
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 6 |
Nodule
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
196 / 7890 (2.48%) |
191 / 7912 (2.41%) |
occurrences causally related to treatment / all
|
0 / 235 |
1 / 238 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
8 / 7912 (0.10%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyp
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Puncture site haemorrhage
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
subjects affected / exposed
|
12 / 7890 (0.15%) |
12 / 7912 (0.15%) |
occurrences causally related to treatment / all
|
0 / 14 |
1 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Spinal pain
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stent embolisation
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden cardiac death
|
|
|
subjects affected / exposed
|
22 / 7890 (0.28%) |
24 / 7912 (0.30%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 22 |
0 / 24 |
Sudden death
|
|
|
subjects affected / exposed
|
56 / 7890 (0.71%) |
57 / 7912 (0.72%) |
occurrences causally related to treatment / all
|
0 / 56 |
1 / 57 |
deaths causally related to treatment / all
|
0 / 56 |
1 / 57 |
Systemic inflammatory response syndrome
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis in device
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulcer haemorrhage
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibulitis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
Allergic oedema
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Allergy to arthropod bite
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Allergy to arthropod sting
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Anaphylactic reaction
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Food allergy
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypersensitivity
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Social circumstances
|
|
|
Disability
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Acquired hydrocele
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acquired phimosis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign prostatic hyperplasia
|
|
|
subjects affected / exposed
|
28 / 7890 (0.35%) |
31 / 7912 (0.39%) |
occurrences causally related to treatment / all
|
0 / 28 |
0 / 33 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast enlargement
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical dysplasia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial hyperplasia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epididymal cyst
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epididymitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Genital pain
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gynaecomastia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cyst
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian mass
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic fluid collection
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Penile swelling
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peyronie’s disease
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic disorder
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic obstruction
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatism
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
9 / 7912 (0.11%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatomegaly
|
|
|
subjects affected / exposed
|
8 / 7890 (0.10%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scrotal oedema
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scrotal swelling
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine polyp
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine prolapse
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterovaginal prolapse
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal polyp
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal prolapse
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Acute lung injury
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute pulmonary oedema
|
|
|
subjects affected / exposed
|
14 / 7890 (0.18%) |
12 / 7912 (0.15%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 0 |
Acute respiratory distress syndrome
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute respiratory failure
|
|
|
subjects affected / exposed
|
18 / 7890 (0.23%) |
10 / 7912 (0.13%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 2 |
Apnoea
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Asphyxia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aspiration
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Asthma
|
|
|
subjects affected / exposed
|
8 / 7890 (0.10%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Atelectasis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchial hyperreactivity
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bronchitis chronic
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchopleural fistula
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Bronchopulmonary disease
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
52 / 7890 (0.66%) |
50 / 7912 (0.63%) |
occurrences causally related to treatment / all
|
0 / 74 |
0 / 75 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 3 |
Chronic respiratory failure
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cough
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diaphragmatic disorder
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diaphragmatic paralysis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysphonia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
subjects affected / exposed
|
39 / 7890 (0.49%) |
52 / 7912 (0.66%) |
occurrences causally related to treatment / all
|
0 / 42 |
0 / 55 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Dyspnoea exertional
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
10 / 7912 (0.13%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Emphysema
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
10 / 7912 (0.13%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
7 / 7912 (0.09%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Haemothorax
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydropneumothorax
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrothorax
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Idiopathic pulmonary fibrosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Increased upper airway secretion
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Laryngeal cyst
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal oedema
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngospasm
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung consolidation
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung cyst
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
Lung infiltration
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mediastinal haematoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mediastinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal cyst
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal mucosal hypertrophy
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal polyps
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal septum deviation
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal turbinate hypertrophy
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive airways disorder
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Organising pneumonia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oropharyngeal pain
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthopnoea
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Painful respiration
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal oedema
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
20 / 7890 (0.25%) |
12 / 7912 (0.15%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pleuritic pain
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 0 |
Pneumonitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Productive cough
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary arterial hypertension
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary congestion
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
26 / 7890 (0.33%) |
35 / 7912 (0.44%) |
occurrences causally related to treatment / all
|
1 / 29 |
1 / 35 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 7 |
Pulmonary fibrosis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulmonary haemorrhage
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulmonary hypertension
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulmonary mass
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulmonary oedema
|
|
|
subjects affected / exposed
|
15 / 7890 (0.19%) |
17 / 7912 (0.21%) |
occurrences causally related to treatment / all
|
0 / 15 |
1 / 17 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 4 |
Respiratory arrest
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory disorder
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory distress
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Respiratory failure
|
|
|
subjects affected / exposed
|
24 / 7890 (0.30%) |
18 / 7912 (0.23%) |
occurrences causally related to treatment / all
|
0 / 25 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 10 |
0 / 3 |
Restrictive pulmonary disease
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Sleep apnoea syndrome
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Snoring
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Status asthmaticus
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vocal cord thickening
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wheezing
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Aggression
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Agitation
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol abuse
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol withdrawal syndrome
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcoholism
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety disorder
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
Confusional state
|
|
|
subjects affected / exposed
|
12 / 7890 (0.15%) |
8 / 7912 (0.10%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Conversion disorder
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delirium
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
7 / 7912 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
8 / 7912 (0.10%) |
occurrences causally related to treatment / all
|
0 / 8 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression suicidal
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Disorientation
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysthymic disorder
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Emotional distress
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hallucination
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hallucination, auditory
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impulse-control disorder
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Insomnia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Major depression
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mania
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental disorder
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Panic attack
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychogenic seizure
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychotic disorder
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sleep disorder
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Somatoform disorder cardiovascular
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicidal behaviour
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicidal ideation
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicide attempt
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Acute hepatic failure
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcoholic liver disease
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Bile duct obstruction
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct stenosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct stone
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary colic
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary fistula
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis acute
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
subjects affected / exposed
|
24 / 7890 (0.30%) |
21 / 7912 (0.27%) |
occurrences causally related to treatment / all
|
0 / 25 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
subjects affected / exposed
|
24 / 7890 (0.30%) |
19 / 7912 (0.24%) |
occurrences causally related to treatment / all
|
0 / 24 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cholecystitis chronic
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
28 / 7890 (0.35%) |
30 / 7912 (0.38%) |
occurrences causally related to treatment / all
|
0 / 29 |
0 / 31 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis obstructive
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholestasis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug-induced liver injury
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder disorder
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder pain
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder perforation
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cirrhosis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatic cyst
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic failure
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Hepatic function abnormal
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
1 / 2 |
2 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic haemorrhage
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic mass
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic steatosis
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis acute
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hepatitis alcoholic
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis toxic
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatocellular injury
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatorenal failure
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatotoxicity
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocholecystis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperbilirubinaemia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic hepatitis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Jaundice
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaundice cholestatic
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver injury
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumobilia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Portal hypertension
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal infection
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Investigations
|
|
|
Activated partial thromboplastin time prolonged
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alanine aminotransferase abnormal
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alanine aminotransferase increased
|
|
|
subjects affected / exposed
|
11 / 7890 (0.14%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
1 / 11 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aspartate aminotransferase abnormal
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aspartate aminotransferase increased
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
1 / 6 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile output abnormal
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood alkaline phosphatase increased
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood bilirubin increased
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatine phosphokinase increased
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood glucose decreased
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood glucose increased
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood potassium decreased
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure decreased
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure increased
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood urea increased
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood urine present
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
C-reactive protein increased
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac murmur
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac stress test abnormal
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid bruit
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ECG signs of myocardial ischaemia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ejection fraction decreased
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram ST segment depression
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gamma-glutamyltransferase increased
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoglobin decreased
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart rate decreased
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart rate increased
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart rate irregular
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic enzyme abnormal
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
8 / 7912 (0.10%) |
occurrences causally related to treatment / all
|
1 / 5 |
2 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
International normalised ratio increased5
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
2 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraocular pressure increased
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver function test abnormal
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Occult blood positive
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oxygen saturation decreased
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic specific antigen increased
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Red blood cell sedimentation rate increased
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scan myocardial perfusion abnormal
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcus test positive
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stroke volume decreased
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transaminases increased
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Troponin I increased
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Troponin increased
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Weight decreased
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
White blood cell count increased
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bilirubin conjugated increased
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
Accident at home
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Accidental overdose
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acetabulum fracture
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia postoperative
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Animal bite
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial injury
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Arterial restenosis
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula thrombosis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthropod sting
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back injury
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone contusion
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain contusion
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Burns first degree
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Burns second degree
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac function disturbance postoperative
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiac procedure complication
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery restenosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest injury
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clavicle fracture
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Comminuted fracture
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Concussion
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Contusion
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery restenosis
|
|
|
subjects affected / exposed
|
28 / 7890 (0.35%) |
19 / 7912 (0.24%) |
occurrences causally related to treatment / all
|
0 / 31 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Eschar
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Excoriation
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extradural haematoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye injury
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye penetration
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Face injury
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
subjects affected / exposed
|
17 / 7890 (0.22%) |
11 / 7912 (0.14%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Femoral neck fracture
|
|
|
subjects affected / exposed
|
12 / 7890 (0.15%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
subjects affected / exposed
|
11 / 7890 (0.14%) |
12 / 7912 (0.15%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Fibula fracture
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Forearm fracture
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foreign body
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fractured sacrum
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorder postoperative
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal stoma complication
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft thrombosis
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gun shot wound
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hand fracture
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head injury
|
|
|
subjects affected / exposed
|
11 / 7890 (0.14%) |
7 / 7912 (0.09%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Heart injury
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
subjects affected / exposed
|
10 / 7890 (0.13%) |
13 / 7912 (0.16%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Humerus fracture
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incision site haematoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incision site haemorrhage
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incisional hernia, obstructive
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inflammation of wound
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Internal injury
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc injury
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaw fracture
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint injury
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kidney contusion
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laceration
|
|
|
subjects affected / exposed
|
9 / 7890 (0.11%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament injury
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament rupture
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament sprain
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb crushing injury
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb injury
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb traumatic amputation
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver contusion
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
subjects affected / exposed
|
8 / 7890 (0.10%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental status changes postoperative
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple fractures
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple injuries
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle rupture
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle strain
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Overdose
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Patella fracture
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Periprosthetic fracture
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perirenal haematoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Poisoning
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post laminectomy syndrome
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural complication
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Post procedural fistula
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural myocardial infarction
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural stroke
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural swelling
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative hernia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative ileus
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Postoperative respiratory failure
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Postoperative thoracic procedure complication
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative thrombosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural complication
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural haemorrhage
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural headache
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural hypotension
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural nausea
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural pain
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural vomiting
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pubis fracture
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary contusion
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal haematoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
subjects affected / exposed
|
9 / 7890 (0.11%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Shunt stenosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skull fracture
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skull fractured base
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue injury
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal column injury
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic rupture
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splinter
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous haematoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
subjects affected / exposed
|
8 / 7890 (0.10%) |
15 / 7912 (0.19%) |
occurrences causally related to treatment / all
|
0 / 10 |
1 / 16 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 5 |
Subdural haemorrhage
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Suture related complication
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Synovial rupture
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon injury
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
subjects affected / exposed
|
8 / 7890 (0.10%) |
8 / 7912 (0.10%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Testicular injury
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thermal burn
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Transfusion reaction
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transplant failure
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic haematoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic intracranial haemorrhage
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic renal injury
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ulna fracture
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary bladder rupture
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular bypass dysfunction
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft complication
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft occlusion
|
|
|
subjects affected / exposed
|
8 / 7890 (0.10%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft thrombosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular procedure complication
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venomous sting
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound evisceration
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound haematoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound necrosis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
Arteriovenous malformation
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial septal defect
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertrophic cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal vessel congenital anomaly
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Syringomyelia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Acute coronary syndrome
|
|
|
subjects affected / exposed
|
17 / 7890 (0.22%) |
17 / 7912 (0.21%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Acute left ventricular failure
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Acute myocardial infarction
|
|
|
subjects affected / exposed
|
359 / 7890 (4.55%) |
303 / 7912 (3.83%) |
occurrences causally related to treatment / all
|
7 / 425 |
9 / 357 |
deaths causally related to treatment / all
|
1 / 44 |
1 / 35 |
Angina pectoris
|
|
|
subjects affected / exposed
|
271 / 7890 (3.43%) |
248 / 7912 (3.13%) |
occurrences causally related to treatment / all
|
0 / 309 |
0 / 282 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Angina unstable
|
|
|
subjects affected / exposed
|
489 / 7890 (6.20%) |
472 / 7912 (5.97%) |
occurrences causally related to treatment / all
|
8 / 618 |
2 / 569 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 4 |
Aortic valve disease
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve disease mixed
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve incompetence
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve stenosis
|
|
|
subjects affected / exposed
|
10 / 7890 (0.13%) |
7 / 7912 (0.09%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Arrhythmia
|
|
|
subjects affected / exposed
|
8 / 7890 (0.10%) |
7 / 7912 (0.09%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
Arrhythmia supraventricular
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
subjects affected / exposed
|
15 / 7890 (0.19%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Arteriospasm coronary
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
135 / 7890 (1.71%) |
123 / 7912 (1.55%) |
occurrences causally related to treatment / all
|
2 / 164 |
0 / 153 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Atrial flutter
|
|
|
subjects affected / exposed
|
27 / 7890 (0.34%) |
27 / 7912 (0.34%) |
occurrences causally related to treatment / all
|
0 / 36 |
0 / 31 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial tachycardia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
56 / 7912 (0.71%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial thrombosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
subjects affected / exposed
|
9 / 7890 (0.11%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block complete
|
|
|
subjects affected / exposed
|
12 / 7890 (0.15%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block first degree
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block second degree
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
8 / 7912 (0.10%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular dissociation
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bifascicular block
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradyarrhythmia
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
19 / 7890 (0.24%) |
24 / 7912 (0.30%) |
occurrences causally related to treatment / all
|
0 / 19 |
1 / 25 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Bundle branch block left
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bundle branch block right
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac aneurysm
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
subjects affected / exposed
|
26 / 7890 (0.33%) |
28 / 7912 (0.35%) |
occurrences causally related to treatment / all
|
0 / 26 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 20 |
0 / 22 |
Cardiac asthma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac discomfort
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorder
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiac failure
|
|
|
subjects affected / exposed
|
178 / 7890 (2.26%) |
155 / 7912 (1.96%) |
occurrences causally related to treatment / all
|
2 / 244 |
3 / 225 |
deaths causally related to treatment / all
|
1 / 36 |
0 / 26 |
Cardiac failure acute
|
|
|
subjects affected / exposed
|
16 / 7890 (0.20%) |
10 / 7912 (0.13%) |
occurrences causally related to treatment / all
|
1 / 16 |
0 / 12 |
deaths causally related to treatment / all
|
1 / 8 |
0 / 2 |
Cardiac failure chronic
|
|
|
subjects affected / exposed
|
19 / 7890 (0.24%) |
17 / 7912 (0.21%) |
occurrences causally related to treatment / all
|
1 / 21 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 2 |
Cardiac failure congestive
|
|
|
subjects affected / exposed
|
135 / 7890 (1.71%) |
125 / 7912 (1.58%) |
occurrences causally related to treatment / all
|
2 / 196 |
1 / 168 |
deaths causally related to treatment / all
|
0 / 13 |
0 / 9 |
Cardiac tamponade
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac valve disease
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
subjects affected / exposed
|
15 / 7890 (0.19%) |
15 / 7912 (0.19%) |
occurrences causally related to treatment / all
|
1 / 15 |
1 / 15 |
deaths causally related to treatment / all
|
1 / 14 |
1 / 15 |
Cardiogenic shock
|
|
|
subjects affected / exposed
|
11 / 7890 (0.14%) |
16 / 7912 (0.20%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 10 |
Cardiomyopathy
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiopulmonary failure
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 5 |
Cardiovascular deconditioning
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiovascular disorder
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 3 |
Cardiovascular insufficiency
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Chronic left ventricular failure
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronotropic incompetence
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Conduction disorder
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congestive cardiomyopathy
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cor pulmonale chronic
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
subjects affected / exposed
|
177 / 7890 (2.24%) |
168 / 7912 (2.12%) |
occurrences causally related to treatment / all
|
0 / 190 |
0 / 185 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 2 |
Coronary artery insufficiency
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Coronary artery occlusion
|
|
|
subjects affected / exposed
|
17 / 7890 (0.22%) |
19 / 7912 (0.24%) |
occurrences causally related to treatment / all
|
1 / 17 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
subjects affected / exposed
|
59 / 7890 (0.75%) |
56 / 7912 (0.71%) |
occurrences causally related to treatment / all
|
3 / 64 |
0 / 59 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diastolic dysfunction
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extrasystoles
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive heart disease
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Intracardiac thrombus
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic cardiomyopathy
|
|
|
subjects affected / exposed
|
14 / 7890 (0.18%) |
11 / 7912 (0.14%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Left ventricular dysfunction
|
|
|
subjects affected / exposed
|
8 / 7890 (0.10%) |
13 / 7912 (0.16%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Left ventricular failure
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
12 / 7912 (0.15%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Left ventricular hypertrophy
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve disease
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
subjects affected / exposed
|
9 / 7890 (0.11%) |
10 / 7912 (0.13%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve stenosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial fibrosis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Myocardial infarction
|
|
|
subjects affected / exposed
|
54 / 7890 (0.68%) |
56 / 7912 (0.71%) |
occurrences causally related to treatment / all
|
1 / 55 |
1 / 56 |
deaths causally related to treatment / all
|
0 / 21 |
1 / 34 |
Myocardial ischaemia
|
|
|
subjects affected / exposed
|
41 / 7890 (0.52%) |
47 / 7912 (0.59%) |
occurrences causally related to treatment / all
|
0 / 45 |
0 / 49 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Myocarditis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nodal arrhythmia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Palpitations
|
|
|
subjects affected / exposed
|
9 / 7890 (0.11%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial haemorrhage
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericarditis constrictive
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postinfarction angina
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prinzmetal angina
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulseless electrical activity
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Right ventricular failure
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Sick sinus syndrome
|
|
|
subjects affected / exposed
|
24 / 7890 (0.30%) |
15 / 7912 (0.19%) |
occurrences causally related to treatment / all
|
0 / 24 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Silent myocardial infarction
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinoatrial block
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus arrest
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus arrhythmia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus tachycardia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular extrasystoles
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachyarrhythmia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
8 / 7890 (0.10%) |
14 / 7912 (0.18%) |
occurrences causally related to treatment / all
|
0 / 11 |
3 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Systolic dysfunction
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Torsade de pointes
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tricuspid valve disease
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Trifascicular block
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular arrhythmia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ventricular dyssynchrony
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular extrasystoles
|
|
|
subjects affected / exposed
|
9 / 7890 (0.11%) |
8 / 7912 (0.10%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular fibrillation
|
|
|
subjects affected / exposed
|
19 / 7890 (0.24%) |
22 / 7912 (0.28%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 5 |
Ventricular tachyarrhythmia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular tachycardia
|
|
|
subjects affected / exposed
|
42 / 7890 (0.53%) |
37 / 7912 (0.47%) |
occurrences causally related to treatment / all
|
1 / 56 |
1 / 41 |
deaths causally related to treatment / all
|
0 / 2 |
1 / 3 |
Congenital coronary artery malformation
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocele
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
Alcoholic seizure
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Altered state of consciousness
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Amyotrophic lateral sclerosis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Aphasia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ataxia
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Balance disorder
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal ganglia infarction
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain injury
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Brain midline shift
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain oedema
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Brain stem haemorrhage
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Brain stem infarction
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Brain stem ischaemia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain stem stroke
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Carotid arteriosclerosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery disease
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery occlusion
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
subjects affected / exposed
|
47 / 7890 (0.60%) |
48 / 7912 (0.61%) |
occurrences causally related to treatment / all
|
0 / 51 |
0 / 54 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cauda equina syndrome
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Central nervous system lesion
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar haemorrhage
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar infarction
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic mononeuropathy
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic neuropathy
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Disturbance in attention
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness
|
|
|
subjects affected / exposed
|
18 / 7890 (0.23%) |
18 / 7912 (0.23%) |
occurrences causally related to treatment / all
|
1 / 18 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Dizziness exertional
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness postural
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysaesthesia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysarthria
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyslalia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dystonia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolic cerebral infarction
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolic stroke
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalomalacia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
7 / 7912 (0.09%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial paresis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Grand mal convulsion
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Guillain-Barre syndrome
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Haemorrhage intracranial
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Haemorrhagic cerebral infarction
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic stroke
|
|
|
subjects affected / exposed
|
19 / 7890 (0.24%) |
15 / 7912 (0.19%) |
occurrences causally related to treatment / all
|
0 / 19 |
2 / 15 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 5 |
Haemorrhagic transformation stroke
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Headache
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hemianopia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiplegic migraine
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocephalus
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypertensive encephalopathy
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoaesthesia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic coma
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic unconsciousness
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotonia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxic-ischaemic encephalopathy
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intercostal neuralgia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracranial aneurysm
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraventricular haemorrhage
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic cerebral infarction
|
|
|
subjects affected / exposed
|
20 / 7890 (0.25%) |
13 / 7912 (0.16%) |
occurrences causally related to treatment / all
|
0 / 22 |
1 / 14 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ischaemic neuropathy
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
subjects affected / exposed
|
97 / 7890 (1.23%) |
94 / 7912 (1.19%) |
occurrences causally related to treatment / all
|
1 / 107 |
1 / 99 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 15 |
Lacunar infarction
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lethargy
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Memory impairment
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningoradiculitis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Migraine
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mononeuritis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Monoparesis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Movement disorder
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve compression
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve root compression
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorder
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Neuralgia
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuritis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuritis cranial
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurological symptom
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normal pressure hydrocephalus
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic intolerance
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraesthesia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraplegia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paresis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parkinson’s disease
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral nerve paresis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyneuropathy
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyneuropathy chronic
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post herpetic neuralgia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Presyncope
|
|
|
subjects affected / exposed
|
16 / 7890 (0.20%) |
16 / 7912 (0.20%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudoradicular syndrome
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radicular syndrome
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiculitis lumbosacral
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiculopathy
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Restless legs syndrome
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retrograde amnesia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reversible ischaemic neurological deficit
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ruptured cerebral aneurysm
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sciatica
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Senile dementia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sensory disturbance
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sensory loss
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Simple partial seizures
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Somnolence
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Spinal claudication
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal cord compression
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal cord disorder
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal haematoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylitic myelopathy
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Status epilepticus
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stupor
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Syncope
|
|
|
subjects affected / exposed
|
79 / 7890 (1.00%) |
72 / 7912 (0.91%) |
occurrences causally related to treatment / all
|
0 / 81 |
0 / 77 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Thalamic infarction
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombotic cerebral infarction
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombotic stroke
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient global amnesia
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
subjects affected / exposed
|
87 / 7890 (1.10%) |
67 / 7912 (0.85%) |
occurrences causally related to treatment / all
|
4 / 98 |
0 / 75 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tremor
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Trigeminal neuralgia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VIIth nerve paralysis
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VIth nerve paralysis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular dementia
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular encephalopathy
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular parkinsonism
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral artery stenosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebrobasilar insufficiency
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo CNS origin
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vocal cord paralysis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
White matter lesion
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral arteriosclerosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral artery embolism
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral artery occlusion
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral artery stenosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral circulatory failure
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haematoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Cerebral infarction
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
15 / 7912 (0.19%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 16 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cerebral ischaemia
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
subjects affected / exposed
|
28 / 7890 (0.35%) |
33 / 7912 (0.42%) |
occurrences causally related to treatment / all
|
0 / 28 |
0 / 33 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 10 |
Cerebrovascular disorder
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cervical myelopathy
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervicobrachial syndrome
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cognitive disorder
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Complex partial seizures
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complex regional pain syndrome
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Convulsion
|
|
|
subjects affected / exposed
|
8 / 7890 (0.10%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Critical illness polyneuropathy
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Dementia
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Dementia Alzheimer’s type
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia with Lewy bodies
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depressed level of consciousness
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Diabetic hyperosmolar coma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
subjects affected / exposed
|
52 / 7890 (0.66%) |
42 / 7912 (0.53%) |
occurrences causally related to treatment / all
|
2 / 54 |
0 / 43 |
deaths causally related to treatment / all
|
1 / 3 |
0 / 1 |
Anaemia macrocytic
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia megaloblastic
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia of chronic disease
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone marrow failure
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone marrow ischaemia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coagulopathy
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Disseminated intravascular coagulation
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
Febrile neutropenia
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Haemolytic anaemia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Haemorrhagic anaemia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hyperprothrombinaemia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypochromic anaemia
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Idiopathic thrombocytopenic purpura
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iron deficiency anaemia
|
|
|
subjects affected / exposed
|
8 / 7890 (0.10%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Jaundice acholuric
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenopathy
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Microcytic anaemia
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polycythaemia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spontaneous haematoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
Deafness
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otosclerosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ototoxicity
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden hearing loss
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tinnitus
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
14 / 7912 (0.18%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo labyrinthine
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular disorder
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Amaurosis fugax
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blindness
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blindness unilateral
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract
|
|
|
subjects affected / exposed
|
16 / 7890 (0.20%) |
16 / 7912 (0.20%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Conjunctivitis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dacryostenosis acquired
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic eye disease
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic retinopathy
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diplopia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorder
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye haemorrhage
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye pain
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eyelid ptosis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glaucoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular fibrosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ocular retrobulbar haemorrhage
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ocular vascular disorder
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ophthalmoplegia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Optic ischaemic neuropathy
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pterygium
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal artery occlusion
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal artery thrombosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal degeneration
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal ischaemia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal tear
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal vascular thrombosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal vein occlusion
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinopathy
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulcerative keratitis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vision blurred
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual acuity reduced
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous haemorrhage
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Abdominal adhesions
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal distension
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal hernia
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal hernia obstructive
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
subjects affected / exposed
|
25 / 7890 (0.32%) |
12 / 7912 (0.15%) |
occurrences causally related to treatment / all
|
1 / 25 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
11 / 7912 (0.14%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal strangulated hernia
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall haematoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall mass
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute abdomen
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcoholic pancreatitis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fissure
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fistula
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anorectal disorder
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendix disorder
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ascites
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Buccal polyp
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
subjects affected / exposed
|
12 / 7890 (0.15%) |
7 / 7912 (0.09%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Colitis ulcerative
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colonic stenosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Constipation
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
11 / 7912 (0.14%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Crohn’s disease
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dental caries
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gastroparesis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diaphragmatic hernia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
subjects affected / exposed
|
21 / 7890 (0.27%) |
23 / 7912 (0.29%) |
occurrences causally related to treatment / all
|
3 / 21 |
3 / 25 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dieulafoy’s vascular malformation
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticular perforation
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
7 / 7912 (0.09%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal polyp
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
2 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
2 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer perforation
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal vascular ectasia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Enteritis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterovesical fistula
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epigastric discomfort
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erosive duodenitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erosive oesophagitis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Faecal incontinence
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Faeces discoloured
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral hernia, obstructive
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Frequent bowel movements
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallstone ileus
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric dysplasia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric haemorrhage
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gastric polyps
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
17 / 7912 (0.21%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gastritis
|
|
|
subjects affected / exposed
|
18 / 7890 (0.23%) |
12 / 7912 (0.15%) |
occurrences causally related to treatment / all
|
2 / 18 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis atrophic
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis haemorrhagic
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroduodenal ulcer
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroduodenitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal angiodysplasia
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal angiodysplasia haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal erosion
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
26 / 7890 (0.33%) |
30 / 7912 (0.38%) |
occurrences causally related to treatment / all
|
0 / 27 |
0 / 31 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Gastrointestinal ischaemia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gastrointestinal motility disorder
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal necrosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal pain
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
subjects affected / exposed
|
18 / 7890 (0.23%) |
14 / 7912 (0.18%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrooesophagitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematochezia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic erosive gastritis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
subjects affected / exposed
|
8 / 7890 (0.10%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoaesthesia oral
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileal ulcer
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
1 / 7 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Ileus paralytic
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
subjects affected / exposed
|
48 / 7890 (0.61%) |
31 / 7912 (0.39%) |
occurrences causally related to treatment / all
|
0 / 50 |
0 / 33 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia, obstructive
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Internal hernia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal infarction
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Intestinal ischaemia
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Intestinal obstruction
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
9 / 7912 (0.11%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Intestinal perforation
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal polyp
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestinal ulcer
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
subjects affected / exposed
|
16 / 7890 (0.20%) |
21 / 7912 (0.27%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lip haematoma
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
10 / 7890 (0.13%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lumbar hernia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mallory-Weiss syndrome
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melaena
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric artery stenosis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric occlusion
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric panniculitis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mouth cyst
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nausea
|
|
|
subjects affected / exposed
|
12 / 7890 (0.15%) |
11 / 7912 (0.14%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema mouth
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedematous pancreatitis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal dysplasia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal perforation
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal ulcer
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal varices haemorrhage
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oral pain
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic calcification
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic disorder
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
subjects affected / exposed
|
15 / 7890 (0.19%) |
15 / 7912 (0.19%) |
occurrences causally related to treatment / all
|
2 / 20 |
2 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
subjects affected / exposed
|
12 / 7890 (0.15%) |
7 / 7912 (0.09%) |
occurrences causally related to treatment / all
|
1 / 13 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Pancreatitis chronic
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis necrotising
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Papilla of Vater stenosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraesthesia oral
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer haemorrhage
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer perforation
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pneumatosis intestinalis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Poor dental condition
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
11 / 7912 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Proctalgia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Proctitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Proctitis ulcerative
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
subjects affected / exposed
|
9 / 7890 (0.11%) |
13 / 7912 (0.16%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal polyp
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal prolapse
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reflux gastritis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal haematoma
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Retroperitoneal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Small intestinal obstruction
|
|
|
subjects affected / exposed
|
9 / 7890 (0.11%) |
11 / 7912 (0.14%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal perforation
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spigelian hernia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stomach mass
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Subileus
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Tooth disorder
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toothache
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia, obstructive
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
16 / 7890 (0.20%) |
18 / 7912 (0.23%) |
occurrences causally related to treatment / all
|
0 / 17 |
1 / 18 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Volvulus
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vomiting
|
|
|
subjects affected / exposed
|
12 / 7890 (0.15%) |
7 / 7912 (0.09%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Actinic keratosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angioedema
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blister
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cold sweat
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decubitus ulcer
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Dermatitis allergic
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot
|
|
|
subjects affected / exposed
|
14 / 7890 (0.18%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Drug eruption
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ecchymosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eczema
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eczema asteatotic
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erythema multiforme
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erythema nodosum
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hyperhidrosis
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Keloid scar
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukocytoclastic vasculitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathic ulcer
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pemphigoid
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pruritus
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psoriasis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyoderma gangrenosum
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash generalised
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin disorder
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin necrosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
subjects affected / exposed
|
8 / 7890 (0.10%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stasis dermatitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Swelling face
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urticaria
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
Acute prerenal failure
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bladder dilatation
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder discomfort
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder dysfunction
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder hypertrophy
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus bladder
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus ureteric
|
|
|
subjects affected / exposed
|
9 / 7890 (0.11%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus urinary
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis glandularis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis noninfective
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis ulcerative
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic nephropathy
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysuria
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glomerulonephritis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glomerulonephritis chronic
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematuria
|
|
|
subjects affected / exposed
|
15 / 7890 (0.19%) |
12 / 7912 (0.15%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Incontinence
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower urinary tract symptoms
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Micturition disorder
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephritic syndrome
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
10 / 7890 (0.13%) |
11 / 7912 (0.14%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrotic syndrome
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurogenic bladder
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pollakiuria
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery arteriosclerosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery dissection
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery stenosis
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal colic
|
|
|
subjects affected / exposed
|
8 / 7890 (0.10%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cyst
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cyst haemorrhage
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure
|
|
|
subjects affected / exposed
|
17 / 7890 (0.22%) |
31 / 7912 (0.39%) |
occurrences causally related to treatment / all
|
0 / 17 |
1 / 34 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 5 |
Renal failure acute
|
|
|
subjects affected / exposed
|
61 / 7890 (0.77%) |
83 / 7912 (1.05%) |
occurrences causally related to treatment / all
|
2 / 79 |
0 / 91 |
deaths causally related to treatment / all
|
1 / 10 |
0 / 11 |
Renal failure chronic
|
|
|
subjects affected / exposed
|
13 / 7890 (0.16%) |
10 / 7912 (0.13%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 0 |
Renal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
subjects affected / exposed
|
8 / 7890 (0.10%) |
9 / 7912 (0.11%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Renal infarct
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal mass
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal pain
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal tubular necrosis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress urinary incontinence
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tubulointerstitial nephritis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric obstruction
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric stenosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral disorder
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary bladder haemorrhage
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary bladder polyp
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary incontinence
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
subjects affected / exposed
|
19 / 7890 (0.24%) |
7 / 7912 (0.09%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Adrenal disorder
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Adrenal insufficiency
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Goitre
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperparathyroidism
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperparathyroidism primary
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperthyroidism
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypothyroidism
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid cyst
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid disorder
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic nodular goitre
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Arthralgia
|
|
|
subjects affected / exposed
|
19 / 7890 (0.24%) |
13 / 7912 (0.16%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Arthritis
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
13 / 7912 (0.16%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis reactive
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthropathy
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Articular calcification
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back disorder
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back pain
|
|
|
subjects affected / exposed
|
27 / 7890 (0.34%) |
20 / 7912 (0.25%) |
occurrences causally related to treatment / all
|
0 / 31 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone erosion
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone fistula
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone lesion
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bone pain
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical spinal stenosis
|
|
|
subjects affected / exposed
|
9 / 7890 (0.11%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondromalacia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondropathy
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Costochondritis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dupuytren’s contracture
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Exostosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fistula
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Flank pain
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot deformity
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gouty arthritis
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemarthrosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inclusion body myositis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal mass
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc degeneration
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc disorder
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc displacement
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
24 / 7890 (0.30%) |
16 / 7912 (0.20%) |
occurrences causally related to treatment / all
|
0 / 25 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint effusion
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint swelling
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb discomfort
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
subjects affected / exposed
|
9 / 7890 (0.11%) |
13 / 7912 (0.16%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metatarsalgia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Monarthritis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle haemorrhage
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle spasms
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
9 / 7890 (0.11%) |
11 / 7912 (0.14%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal discomfort
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
8 / 7912 (0.10%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myalgia
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
9 / 7912 (0.11%) |
occurrences causally related to treatment / all
|
0 / 6 |
2 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myofascial pain syndrome
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myositis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neck pain
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteitis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Osteoarthritis
|
|
|
subjects affected / exposed
|
78 / 7890 (0.99%) |
73 / 7912 (0.92%) |
occurrences causally related to treatment / all
|
0 / 86 |
0 / 81 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteochondrosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoporosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoporotic fracture
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pathological fracture
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periarthritis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyarthritis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polymyalgia rheumatica
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
7 / 7912 (0.09%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Rheumatoid arthritis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
subjects affected / exposed
|
9 / 7890 (0.11%) |
7 / 7912 (0.09%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scoliosis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal column stenosis
|
|
|
subjects affected / exposed
|
16 / 7890 (0.20%) |
13 / 7912 (0.16%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal deformity
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
subjects affected / exposed
|
12 / 7890 (0.15%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylitis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylolysis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Synovitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon disorder
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendonitis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tenosynovitis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tenosynovitis stenosans
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral foraminal stenosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Abdominal abscess
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal sepsis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall abscess
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall infection
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess jaw
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute hepatitis B
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute pulmonary histoplasmosis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Amoebiasis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendiceal abscess
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
subjects affected / exposed
|
19 / 7890 (0.24%) |
15 / 7912 (0.19%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis perforated
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerotic gangrene
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Arthritis bacterial
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis infective
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial pyelonephritis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial sepsis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary sepsis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone abscess
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Borrelia infection
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
subjects affected / exposed
|
18 / 7890 (0.23%) |
24 / 7912 (0.30%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 27 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Bronchopneumonia
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
12 / 7912 (0.15%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 4 |
Bursitis infective
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Campylobacter gastroenteritis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carbuncle
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter site infection
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
subjects affected / exposed
|
46 / 7890 (0.58%) |
38 / 7912 (0.48%) |
occurrences causally related to treatment / all
|
0 / 53 |
0 / 44 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis gangrenous
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cellulitis staphylococcal
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis suppurative
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cholecystitis infective
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Chronic sinusitis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile infection
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dengue fever
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related infection
|
|
|
subjects affected / exposed
|
8 / 7890 (0.10%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Device related sepsis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot infection
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gangrene
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea infectious
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Disseminated tuberculosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Diverticulitis
|
|
|
subjects affected / exposed
|
11 / 7890 (0.14%) |
15 / 7912 (0.19%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Dysentery
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear infection
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Echinococciasis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Empyema
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis bacterial
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis enterococcal
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Endocarditis staphylococcal
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometritis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endophthalmitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis infectious
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterobacter infection
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterococcal bacteraemia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterococcal infection
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Enterococcal sepsis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Enterocolitis infectious
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epiglottitis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
subjects affected / exposed
|
14 / 7890 (0.18%) |
8 / 7912 (0.10%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia bacteraemia
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia infection
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
External ear cellulitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extradural abscess
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Febrile infection
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fungal oesophagitis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder empyema
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gangrene
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis viral
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
29 / 7890 (0.37%) |
31 / 7912 (0.39%) |
occurrences causally related to treatment / all
|
0 / 32 |
0 / 34 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis rotavirus
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis salmonella
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal viral infection
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Genital infection fungal
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Giardiasis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft infection
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin abscess
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
H1N1 influenza
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HIV infection
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Haematoma infection
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Helicobacter gastritis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Helicobacter infection
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis A
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis B
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis C
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis E
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis viral
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster ophthalmic
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Histoplasmosis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implant site infection
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected bites
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected skin ulcer
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Infectious pleural effusion
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective exacerbation of chronic obstructive airways disease
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective myositis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
7 / 7912 (0.09%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Intertrigo candida
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral discitis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Keratitis herpetic
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kidney infection
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Klebsiella bacteraemia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Klebsiella sepsis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngitis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leptospirosis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver abscess
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lobar pneumonia
|
|
|
subjects affected / exposed
|
17 / 7890 (0.22%) |
9 / 7912 (0.11%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Localised infection
|
|
|
subjects affected / exposed
|
9 / 7890 (0.11%) |
9 / 7912 (0.11%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
10 / 7890 (0.13%) |
8 / 7912 (0.10%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung abscess
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung infection
|
|
|
subjects affected / exposed
|
8 / 7890 (0.10%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lyme disease
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphangitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mastoiditis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mediastinitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis bacterial
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Meningitis cryptococcal
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Mycoplasma infection
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mycotoxicosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasopharyngitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrotising fasciitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Oesophageal candidiasis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oral candidiasis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orchitis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
10 / 7912 (0.13%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis chronic
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis media
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis media chronic
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paronychia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parotitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perineal abscess
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periorbital cellulitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal abscess
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Peritonsillar abscess
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonsillitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngitis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasmodium vivax infection
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumococcal sepsis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
subjects affected / exposed
|
160 / 7890 (2.03%) |
139 / 7912 (1.76%) |
occurrences causally related to treatment / all
|
0 / 176 |
0 / 157 |
deaths causally related to treatment / all
|
0 / 20 |
0 / 18 |
Pneumonia bacterial
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Pneumonia chlamydial
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Pneumonia klebsiella
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia necrotising
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia streptococcal
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia viral
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural infection
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative abscess
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic abscess
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudomembranous colitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudomonal bacteraemia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudomonas infection
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psoas abscess
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary sepsis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary tuberculosis
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
12 / 7912 (0.15%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis chronic
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyopneumothorax
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Respiratory tract infection
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
8 / 7912 (0.10%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Respiratory tract infection viral
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal abscess
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal infection
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salmonella sepsis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salmonellosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scrotal abscess
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scrub typhus
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sepsis
|
|
|
subjects affected / exposed
|
23 / 7890 (0.29%) |
35 / 7912 (0.44%) |
occurrences causally related to treatment / all
|
0 / 25 |
0 / 37 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 15 |
Sepsis syndrome
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Septic embolus
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Septic shock
|
|
|
subjects affected / exposed
|
25 / 7890 (0.32%) |
9 / 7912 (0.11%) |
occurrences causally related to treatment / all
|
0 / 26 |
1 / 10 |
deaths causally related to treatment / all
|
0 / 17 |
0 / 3 |
Sialoadenitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinobronchitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinusitis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin infection
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Soft tissue infection
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal bacteraemia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal infection
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
6 / 7912 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal osteomyelitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcal bacteraemia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcal infection
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Streptococcal sepsis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subacute endocarditis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous abscess
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Superinfection
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suspected transmission of an infectious agent via product
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tinea pedis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tongue abscess
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsillitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth abscess
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheobronchitis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheobronchitis viral
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tuberculosis
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
subjects affected / exposed
|
3 / 7890 (0.04%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Urethritis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
36 / 7890 (0.46%) |
43 / 7912 (0.54%) |
occurrences causally related to treatment / all
|
0 / 49 |
0 / 44 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Urinary tract infection bacterial
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Urinary tract infection pseudomonal
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
subjects affected / exposed
|
15 / 7890 (0.19%) |
14 / 7912 (0.18%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Vaginal abscess
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicella
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound sepsis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol poisoning
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis bacterial
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular neuronitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral infection
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Viral tracheitis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral upper respiratory tract infection
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection
|
|
|
subjects affected / exposed
|
6 / 7890 (0.08%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection staphylococcal
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Acidosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cachexia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Decreased appetite
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dehydration
|
|
|
subjects affected / exposed
|
24 / 7890 (0.30%) |
33 / 7912 (0.42%) |
occurrences causally related to treatment / all
|
0 / 27 |
0 / 33 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Diabetes mellitus
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus inadequate control
|
|
|
subjects affected / exposed
|
8 / 7890 (0.10%) |
26 / 7912 (0.33%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 29 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic complication
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrolyte imbalance
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Failure to thrive
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Fluid overload
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fluid retention
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fructose intolerance
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gout
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
5 / 7912 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
5 / 7890 (0.06%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
subjects affected / exposed
|
9 / 7890 (0.11%) |
11 / 7912 (0.14%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Hyperlipidaemia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperosmolar state
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertriglyceridaemia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoalbuminaemia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypocalcaemia
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
26 / 7890 (0.33%) |
24 / 7912 (0.30%) |
occurrences causally related to treatment / all
|
0 / 28 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
7 / 7890 (0.09%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Hypomagnesaemia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
8 / 7890 (0.10%) |
10 / 7912 (0.13%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypophosphataemia
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
subjects affected / exposed
|
4 / 7890 (0.05%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Insulin-requiring type 2 diabetes mellitus
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ketoacidosis
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
3 / 7912 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metabolic acidosis
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Metabolic syndrome
|
|
|
subjects affected / exposed
|
0 / 7890 (0.00%) |
1 / 7912 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obesity
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
4 / 7912 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 1 diabetes mellitus
|
|
|
subjects affected / exposed
|
2 / 7890 (0.03%) |
2 / 7912 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
subjects affected / exposed
|
37 / 7890 (0.47%) |
27 / 7912 (0.34%) |
occurrences causally related to treatment / all
|
0 / 38 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Vitamin B12 deficiency
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitamin D deficiency
|
|
|
subjects affected / exposed
|
1 / 7890 (0.01%) |
0 / 7912 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |