Serious adverse events
|
Placebo |
Lorcaserin 10 mg |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
2021 / 5992 (33.73%) |
1974 / 5995 (32.93%) |
number of deaths (all causes)
|
202 |
219 |
number of deaths resulting from adverse events
|
121 |
132 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Acute leukaemia
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute myeloid leukaemia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma gastric
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma of appendix
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma pancreas
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
1 / 1 |
Adrenal adenoma
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal gland cancer
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal neoplasm
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angiomyolipoma
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendix cancer
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Atypical fibroxanthoma
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
B-cell lymphoma
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
B-cell lymphoma stage III
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign gastric neoplasm
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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 ampulla of Vater
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
1 / 5992 (0.02%) |
0 / 5995 (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 thyroid gland
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign renal neoplasm
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign small intestinal neoplasm
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary neoplasm
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
subjects affected / exposed
|
5 / 5992 (0.08%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer recurrent
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neoplasm
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma recurrent
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone cancer
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Brain neoplasm
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer
|
|
|
subjects affected / exposed
|
9 / 5992 (0.15%) |
11 / 5995 (0.18%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer in situ
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervix carcinoma stage IV
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cholangiocarcinoma
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Choroid melanoma
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Choroid neoplasm
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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
|
3 / 5992 (0.05%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Chronic myeloid leukaemia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clear cell renal cell carcinoma
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon adenoma
|
|
|
subjects affected / exposed
|
11 / 5992 (0.18%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
2 / 12 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
subjects affected / exposed
|
7 / 5992 (0.12%) |
9 / 5995 (0.15%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon neoplasm
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal cancer stage IV
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Diffuse large B-cell lymphoma
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Endometrial adenocarcinoma
|
|
|
subjects affected / exposed
|
5 / 5992 (0.08%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial cancer
|
|
|
subjects affected / exposed
|
7 / 5992 (0.12%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extranodal marginal zone B-cell lymphoma (MALT type)
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibroadenoma of breast
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibroma
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Follicular thyroid cancer
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric cancer
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric cancer stage 0
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal stromal tumour
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glioblastoma
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Glioblastoma multiforme
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Hepatic cancer
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Hepatic cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatocellular carcinoma
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hodgkin's disease
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraductal papillary mucinous neoplasm
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraductal papillary-mucinous carcinoma of pancreas
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraductal papilloma of breast
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraductal proliferative breast lesion
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive breast carcinoma
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive ductal breast carcinoma
|
|
|
subjects affected / exposed
|
8 / 5992 (0.13%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Keratoacanthoma
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kidney angiomyolipoma
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Lung adenocarcinoma stage 0
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Lung cancer metastatic
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Lung carcinoma cell type unspecified stage III
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung neoplasm
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung neoplasm malignant
|
|
|
subjects affected / exposed
|
6 / 5992 (0.10%) |
13 / 5995 (0.22%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung squamous cell carcinoma stage II
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphoma
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
subjects affected / exposed
|
17 / 5992 (0.28%) |
20 / 5995 (0.33%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma in situ
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma stage I
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Malignant neoplasm of spinal cord
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Malignant sweat gland neoplasm
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melanocytic naevus
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningioma
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningioma benign
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to bone
|
|
|
subjects affected / exposed
|
6 / 5992 (0.10%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastases to liver
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Metastases to lung
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to lymph nodes
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastasis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic carcinoma of the bladder
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastatic malignant melanoma
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastatic renal cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mucinous cystadenocarcinoma ovary
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Mycosis fungoides
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelodysplastic syndrome
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myxofibrosarcoma
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasopharyngeal cancer
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm prostate
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm skin
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroendocrine carcinoma metastatic
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroendocrine tumour
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nodular melanoma
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-small cell lung cancer
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Non-small cell lung cancer stage I
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Oesophageal adenocarcinoma metastatic
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Oesophageal carcinoma
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Oropharyngeal cancer
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian adenoma
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
0 / 5992 (0.00%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 4 |
Pancreatic carcinoma metastatic
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
Pancreatic neuroendocrine tumour
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papillary serous endometrial carcinoma
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papillary thyroid cancer
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal carcinoma metastatic
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pharyngeal cancer
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pituitary tumour benign
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Polycythaemia vera
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
subjects affected / exposed
|
51 / 5992 (0.85%) |
50 / 5995 (0.83%) |
occurrences causally related to treatment / all
|
0 / 51 |
1 / 50 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Prostate cancer metastatic
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Prostate cancer recurrent
|
|
|
subjects affected / exposed
|
6 / 5992 (0.10%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Prostate cancer stage II
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal cancer
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectosigmoid cancer
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cell carcinoma
|
|
|
subjects affected / exposed
|
7 / 5992 (0.12%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal neoplasm
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland adenoma
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland cancer
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin squamous cell carcinoma metastatic
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Small cell lung cancer
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small cell lung cancer extensive stage
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Small cell lung cancer metastatic
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Squamous cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of head and neck
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Squamous cell carcinoma of lung
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Squamous cell carcinoma of skin
|
|
|
subjects affected / exposed
|
5 / 5992 (0.08%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the oral cavity
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the tongue
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tongue neoplasm malignant stage unspecified
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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 / 5992 (0.07%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteral neoplasm
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral cancer
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine cancer
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulval cancer stage 0
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Waldenstrom's macroglobulinaemia
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Accelerated hypertension
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic aneurysm
|
|
|
subjects affected / exposed
|
11 / 5992 (0.18%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic dissection
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Aortic stenosis
|
|
|
subjects affected / exposed
|
7 / 5992 (0.12%) |
14 / 5995 (0.23%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Arterial occlusive disease
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial stenosis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Arteriovenous fistula
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
13 / 5992 (0.22%) |
12 / 5995 (0.20%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dry gangrene
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertension
|
|
|
subjects affected / exposed
|
14 / 5992 (0.23%) |
10 / 5995 (0.17%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hypertensive crisis
|
|
|
subjects affected / exposed
|
7 / 5992 (0.12%) |
8 / 5995 (0.13%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotension
|
|
|
subjects affected / exposed
|
10 / 5992 (0.17%) |
16 / 5995 (0.27%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemic shock
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Iliac artery disease
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intermittent claudication
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemia
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leriche syndrome
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphoedema
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant hypertension
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Microscopic polyangiitis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
subjects affected / exposed
|
11 / 5992 (0.18%) |
14 / 5995 (0.23%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Peripheral artery aneurysm
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery dissection
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery occlusion
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral vascular disorder
|
|
|
subjects affected / exposed
|
7 / 5992 (0.12%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral venous disease
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Poor peripheral circulation
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reperfusion injury
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shock haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian artery stenosis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian vein thrombosis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis superficial
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis limb
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthenia
|
|
|
subjects affected / exposed
|
5 / 5992 (0.08%) |
9 / 5995 (0.15%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac death
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Chest discomfort
|
|
|
subjects affected / exposed
|
7 / 5992 (0.12%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest pain
|
|
|
subjects affected / exposed
|
21 / 5992 (0.35%) |
16 / 5995 (0.27%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complication associated with device
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cyst
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Death
|
|
|
subjects affected / exposed
|
12 / 5992 (0.20%) |
16 / 5995 (0.27%) |
occurrences causally related to treatment / all
|
1 / 12 |
2 / 16 |
deaths causally related to treatment / all
|
1 / 12 |
2 / 16 |
Drug withdrawal syndrome
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Exercise tolerance decreased
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fatigue
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal complication associated with device
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised oedema
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hernia pain
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypothermia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implant site erosion
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated hernia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infusion site extravasation
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Localised oedema
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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 / 5992 (0.03%) |
0 / 5995 (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 haemorrhage
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
132 / 5992 (2.20%) |
133 / 5995 (2.22%) |
occurrences causally related to treatment / all
|
0 / 153 |
1 / 164 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral swelling
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stent-graft endoleak
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden cardiac death
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Sudden death
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Systemic inflammatory response syndrome
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent occlusion
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent restenosis
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent thrombosis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
Anaphylactic reaction
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaphylactic shock
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug hypersensitivity
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypersensitivity
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Social circumstances
|
|
|
Convalescent
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Spousal abuse
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Acquired hydrocele
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adnexa uteri mass
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign prostatic hyperplasia
|
|
|
subjects affected / exposed
|
10 / 5992 (0.17%) |
7 / 5995 (0.12%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast enlargement
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast fibrosis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast hyperplasia
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast pain
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast ulceration
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystocele
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial hyperplasia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erectile dysfunction
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Female genital tract fistula
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Mastoptosis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orchitis noninfective
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Organic erectile dysfunction
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cyst
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic pain
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic prolapse
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Penis disorder
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postmenopausal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Priapism
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatism
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatomegaly
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scrotal haematocoele
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine polyp
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine prolapse
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal prolapse
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Acute pulmonary oedema
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute respiratory distress syndrome
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute respiratory failure
|
|
|
subjects affected / exposed
|
28 / 5992 (0.47%) |
35 / 5995 (0.58%) |
occurrences causally related to treatment / all
|
1 / 31 |
0 / 37 |
deaths causally related to treatment / all
|
1 / 3 |
0 / 5 |
Allergic bronchitis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aspiration
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthma
|
|
|
subjects affected / exposed
|
9 / 5992 (0.15%) |
12 / 5995 (0.20%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atelectasis
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchial hyperreactivity
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis chronic
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
43 / 5992 (0.72%) |
39 / 5995 (0.65%) |
occurrences causally related to treatment / all
|
0 / 53 |
0 / 58 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Chronic respiratory failure
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cough
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
subjects affected / exposed
|
38 / 5992 (0.63%) |
27 / 5995 (0.45%) |
occurrences causally related to treatment / all
|
1 / 40 |
0 / 27 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Dyspnoea exertional
|
|
|
subjects affected / exposed
|
11 / 5992 (0.18%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Emphysema
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemothorax
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiccups
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypercapnia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
subjects affected / exposed
|
6 / 5992 (0.10%) |
8 / 5995 (0.13%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Idiopathic pulmonary fibrosis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal granuloma
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal mass
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Mediastinal haematoma
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mediastinal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal obstruction
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal polyps
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive airways disorder
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal fistula
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pickwickian syndrome
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
10 / 5992 (0.17%) |
12 / 5995 (0.20%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleurisy
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleuritic pain
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pneumonitis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulmonary arterial hypertension
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
26 / 5992 (0.43%) |
20 / 5995 (0.33%) |
occurrences causally related to treatment / all
|
1 / 27 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Pulmonary fibrosis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pulmonary granuloma
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary haemorrhage
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary hypertension
|
|
|
subjects affected / exposed
|
14 / 5992 (0.23%) |
14 / 5995 (0.23%) |
occurrences causally related to treatment / all
|
4 / 14 |
1 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary mass
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
subjects affected / exposed
|
8 / 5992 (0.13%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Pulmonary sarcoidosis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory arrest
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory distress
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Respiratory failure
|
|
|
subjects affected / exposed
|
14 / 5992 (0.23%) |
14 / 5995 (0.23%) |
occurrences causally related to treatment / all
|
1 / 14 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Sleep apnoea syndrome
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachypnoea
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsillar hypertrophy
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Agitation
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol abuse
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol withdrawal syndrome
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anger
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Confusional state
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
12 / 5995 (0.20%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delirium
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Depression
|
|
|
subjects affected / exposed
|
5 / 5992 (0.08%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hallucination
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Insomnia
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Major depression
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental disorder due to a general medical condition
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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 / 5992 (0.10%) |
10 / 5995 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nightmare
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post-traumatic stress disorder
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Somatic delusion
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicidal ideation
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
9 / 5995 (0.15%) |
occurrences causally related to treatment / all
|
3 / 4 |
6 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicide attempt
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product issues
|
|
|
Device dislocation
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device failure
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device loosening
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device pacing issue
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lead dislodgement
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Autoimmune hepatitis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct obstruction
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct stone
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary colic
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary dyskinesia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
subjects affected / exposed
|
14 / 5992 (0.23%) |
10 / 5995 (0.17%) |
occurrences causally related to treatment / all
|
1 / 14 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
subjects affected / exposed
|
14 / 5992 (0.23%) |
12 / 5995 (0.20%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis chronic
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
24 / 5992 (0.40%) |
14 / 5995 (0.23%) |
occurrences causally related to treatment / all
|
0 / 25 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis obstructive
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic hepatic failure
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cirrhosis alcoholic
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cryptogenic cirrhosis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug-induced liver injury
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cirrhosis
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Hepatic cyst
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic function abnormal
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic mass
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic steatosis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic vascular thrombosis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver disorder
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver injury
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-alcoholic fatty liver
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Portal vein thrombosis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Ammonia increased
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic bruit
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood calcium decreased
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood glucose increased
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood immunoglobulin G decreased
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood potassium increased
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure increased
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood sodium increased
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood urea increased
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Body temperature increased
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coagulation test abnormal
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ECG signs of myocardial ischaemia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ejection fraction decreased
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram QT prolonged
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram ST segment depression
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram abnormal
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glycosylated haemoglobin increased
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoglobin decreased
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart rate decreased
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
International normalised ratio abnormal
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
International normalised ratio increased
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver function test abnormal
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver function test increased
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
N-terminal prohormone brain natriuretic peptide increased
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Platelet count decreased
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prothrombin time prolonged
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary arterial pressure increased
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Troponin T increased
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Troponin increased
|
|
|
subjects affected / exposed
|
8 / 5992 (0.13%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
White blood cell count increased
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
Abdominal injury
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
1 / 5992 (0.02%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol poisoning
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia postoperative
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anastomotic ulcer haemorrhage
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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 / 5992 (0.02%) |
0 / 5995 (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
|
4 / 5992 (0.07%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial bypass thrombosis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial injury
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder injury
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain contusion
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiac contusion
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac valve replacement complication
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cartilage injury
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical vertebral fracture
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest injury
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clavicle fracture
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Concussion
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Contusion
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis radiation
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delayed recovery from anaesthesia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extradural haematoma
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
subjects affected / exposed
|
15 / 5992 (0.25%) |
21 / 5995 (0.35%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
10 / 5995 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Forearm fracture
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hand fracture
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head injury
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
subjects affected / exposed
|
5 / 5992 (0.08%) |
10 / 5995 (0.17%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
subjects affected / exposed
|
6 / 5992 (0.10%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ilium fracture
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated incisional hernia
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incision site complication
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incision site haemorrhage
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incomplete spinal fusion
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intentional overdose
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal anastomosis complication
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaw fracture
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint capsule rupture
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint dislocation postoperative
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint injury
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kidney contusion
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laceration
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament rupture
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament sprain
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb injury
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb traumatic amputation
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver contusion
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental status changes postoperative
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple fractures
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple injuries
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle strain
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Patella fracture
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periprosthetic fracture
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonitis chemical
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax traumatic
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post laminectomy syndrome
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural bile leak
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural complication
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Post procedural discharge
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematuria
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural myocardial infarction
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural swelling
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative fever
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative ileus
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative renal failure
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative respiratory failure
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative thoracic procedure complication
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound complication
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postpericardiotomy syndrome
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural complication
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural haemorrhage
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural hypotension
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural pain
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural pneumothorax
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pubis fracture
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
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
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
subjects affected / exposed
|
9 / 5992 (0.15%) |
9 / 5995 (0.15%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
subjects affected / exposed
|
9 / 5992 (0.15%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
1 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
Scapula fracture
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seroma
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shunt malfunction
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shunt occlusion
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin abrasion
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skull fracture
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic rupture
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Stab wound
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
7 / 5992 (0.12%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Tendon rupture
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic arthritis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic haematoma
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic haemorrhage
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic haemothorax
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic intracranial haemorrhage
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary retention postoperative
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm ruptured
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Weaning failure
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Wound haematoma
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
Atrial septal defect
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Choledochal cyst
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Developmental hip dysplasia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal arteriovenous malformation
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocele
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertrophic cardiomyopathy
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Microgenia
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Acute coronary syndrome
|
|
|
subjects affected / exposed
|
14 / 5992 (0.23%) |
11 / 5995 (0.18%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute left ventricular failure
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute myocardial infarction
|
|
|
subjects affected / exposed
|
117 / 5992 (1.95%) |
105 / 5995 (1.75%) |
occurrences causally related to treatment / all
|
1 / 131 |
0 / 118 |
deaths causally related to treatment / all
|
1 / 7 |
0 / 3 |
Angina pectoris
|
|
|
subjects affected / exposed
|
123 / 5992 (2.05%) |
142 / 5995 (2.37%) |
occurrences causally related to treatment / all
|
0 / 136 |
0 / 152 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
subjects affected / exposed
|
106 / 5992 (1.77%) |
113 / 5995 (1.88%) |
occurrences causally related to treatment / all
|
1 / 115 |
0 / 129 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Anginal equivalent
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve disease
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve incompetence
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
1 / 4 |
2 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve stenosis
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
9 / 5995 (0.15%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Arteriospasm coronary
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
102 / 5992 (1.70%) |
105 / 5995 (1.75%) |
occurrences causally related to treatment / all
|
2 / 122 |
3 / 120 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
subjects affected / exposed
|
22 / 5992 (0.37%) |
21 / 5995 (0.35%) |
occurrences causally related to treatment / all
|
0 / 28 |
3 / 23 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial tachycardia
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block complete
|
|
|
subjects affected / exposed
|
7 / 5992 (0.12%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block first degree
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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
|
3 / 5992 (0.05%) |
7 / 5995 (0.12%) |
occurrences causally related to treatment / all
|
1 / 3 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradyarrhythmia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
17 / 5992 (0.28%) |
18 / 5995 (0.30%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bundle branch block bilateral
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bundle branch block left
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bundle branch block right
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac aneurysm
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
subjects affected / exposed
|
19 / 5992 (0.32%) |
17 / 5995 (0.28%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 11 |
0 / 11 |
Cardiac discomfort
|
|
|
subjects affected / exposed
|
7 / 5992 (0.12%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorder
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiac failure
|
|
|
subjects affected / exposed
|
21 / 5992 (0.35%) |
18 / 5995 (0.30%) |
occurrences causally related to treatment / all
|
0 / 25 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Cardiac failure acute
|
|
|
subjects affected / exposed
|
5 / 5992 (0.08%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure chronic
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure congestive
|
|
|
subjects affected / exposed
|
106 / 5992 (1.77%) |
91 / 5995 (1.52%) |
occurrences causally related to treatment / all
|
2 / 139 |
3 / 124 |
deaths causally related to treatment / all
|
1 / 3 |
0 / 1 |
Cardiac perforation
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac tamponade
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac valve disease
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac ventricular thrombosis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
subjects affected / exposed
|
6 / 5992 (0.10%) |
7 / 5995 (0.12%) |
occurrences causally related to treatment / all
|
0 / 6 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 5 |
1 / 6 |
Cardiogenic shock
|
|
|
subjects affected / exposed
|
5 / 5992 (0.08%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
1 / 3 |
0 / 2 |
Cardiomyopathy
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiopulmonary failure
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Cardiovascular disorder
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiovascular insufficiency
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cor pulmonale
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cor pulmonale acute
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cor pulmonale chronic
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
78 / 5992 (1.30%) |
87 / 5995 (1.45%) |
occurrences causally related to treatment / all
|
0 / 80 |
3 / 92 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 8 |
Coronary artery occlusion
|
|
|
subjects affected / exposed
|
6 / 5992 (0.10%) |
8 / 5995 (0.13%) |
occurrences causally related to treatment / all
|
0 / 6 |
1 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery perforation
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
subjects affected / exposed
|
13 / 5992 (0.22%) |
17 / 5995 (0.28%) |
occurrences causally related to treatment / all
|
0 / 13 |
1 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diastolic dysfunction
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperdynamic left ventricle
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Intracardiac thrombus
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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
|
4 / 5992 (0.07%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kounis syndrome
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left atrial dilatation
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left ventricular dysfunction
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left ventricular failure
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Microvascular coronary artery disease
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve disease
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
subjects affected / exposed
|
12 / 5992 (0.20%) |
12 / 5995 (0.20%) |
occurrences causally related to treatment / all
|
3 / 12 |
4 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve prolapse
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve stenosis
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
subjects affected / exposed
|
31 / 5992 (0.52%) |
36 / 5995 (0.60%) |
occurrences causally related to treatment / all
|
2 / 31 |
0 / 38 |
deaths causally related to treatment / all
|
1 / 9 |
0 / 4 |
Myocardial ischaemia
|
|
|
subjects affected / exposed
|
16 / 5992 (0.27%) |
14 / 5995 (0.23%) |
occurrences causally related to treatment / all
|
1 / 17 |
1 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 3 |
Palpitations
|
|
|
subjects affected / exposed
|
5 / 5992 (0.08%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial cyst
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial haemorrhage
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericarditis constrictive
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prinzmetal angina
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary valve incompetence
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulseless electrical activity
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
1 / 1 |
Right ventricular failure
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus node dysfunction
|
|
|
subjects affected / exposed
|
6 / 5992 (0.10%) |
15 / 5995 (0.25%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus tachycardia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
9 / 5992 (0.15%) |
11 / 5995 (0.18%) |
occurrences causally related to treatment / all
|
0 / 9 |
1 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systolic dysfunction
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tricuspid valve incompetence
|
|
|
subjects affected / exposed
|
7 / 5992 (0.12%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
3 / 7 |
2 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular arrhythmia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular fibrillation
|
|
|
subjects affected / exposed
|
8 / 5992 (0.13%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Ventricular tachyarrhythmia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
22 / 5992 (0.37%) |
13 / 5995 (0.22%) |
occurrences causally related to treatment / all
|
0 / 27 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Nervous system disorders
|
|
|
Amnesia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ataxia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Balance disorder
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal ganglia haemorrhage
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Basal ganglia infarction
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bickerstaff's encephalitis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
3 / 5992 (0.05%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Brain stem haemorrhage
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Brain stem infarction
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain stem stroke
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery disease
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery occlusion
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
subjects affected / exposed
|
17 / 5992 (0.28%) |
15 / 5995 (0.25%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid sinus syndrome
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Central nervous system necrosis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
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
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral circulatory failure
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral infarction
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
9 / 5995 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrospinal fluid leakage
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
subjects affected / exposed
|
41 / 5992 (0.68%) |
29 / 5995 (0.48%) |
occurrences causally related to treatment / all
|
3 / 42 |
1 / 31 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
Cerebrovascular disorder
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical cord compression
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical myelopathy
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical radiculopathy
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervicogenic headache
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complex partial seizures
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cranial nerve palsies multiple
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cubital tunnel syndrome
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Dementia Alzheimer's type
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic coma
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness
|
|
|
subjects affected / exposed
|
9 / 5992 (0.15%) |
14 / 5995 (0.23%) |
occurrences causally related to treatment / all
|
0 / 9 |
2 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness postural
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysarthria
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolic cerebral infarction
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolic stroke
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial paralysis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Frontal lobe epilepsy
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Guillain-Barre syndrome
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic stroke
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Headache
|
|
|
subjects affected / exposed
|
9 / 5992 (0.15%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
1 / 10 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic encephalopathy
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive encephalopathy
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoaesthesia
|
|
|
subjects affected / exposed
|
5 / 5992 (0.08%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxic-ischaemic encephalopathy
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
IIIrd nerve paralysis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracranial aneurysm
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ischaemic stroke
|
|
|
subjects affected / exposed
|
14 / 5992 (0.23%) |
13 / 5995 (0.22%) |
occurrences causally related to treatment / all
|
0 / 14 |
1 / 14 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Lacunar infarction
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar radiculopathy
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbosacral radiculopathy
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Migraine
|
|
|
subjects affected / exposed
|
5 / 5992 (0.08%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Migraine with aura
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Motor neurone disease
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myasthenia gravis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelomalacia
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelopathy
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myoclonus
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve compression
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve root compression
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuralgia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuromyelitis optica spectrum disorder
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normal pressure hydrocephalus
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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 / 5992 (0.02%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parkinson's disease
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parkinsonism
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral sensory neuropathy
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peroneal nerve palsy
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Petit mal epilepsy
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Presyncope
|
|
|
subjects affected / exposed
|
13 / 5992 (0.22%) |
9 / 5995 (0.15%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radial nerve palsy
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radicular pain
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sciatica
|
|
|
subjects affected / exposed
|
7 / 5992 (0.12%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seizure
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
10 / 5995 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Serotonin syndrome
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
4 / 4 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Simple partial seizures
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Slow speech
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Somnolence
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal claudication
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylitic myelopathy
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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
|
2 / 5992 (0.03%) |
9 / 5995 (0.15%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Superficial siderosis of central nervous system
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Superior sagittal sinus thrombosis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Syncope
|
|
|
subjects affected / exposed
|
49 / 5992 (0.82%) |
54 / 5995 (0.90%) |
occurrences causally related to treatment / all
|
3 / 51 |
1 / 62 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Thalamus haemorrhage
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic encephalopathy
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient global amnesia
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
subjects affected / exposed
|
38 / 5992 (0.63%) |
46 / 5995 (0.77%) |
occurrences causally related to treatment / all
|
0 / 39 |
3 / 55 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transverse sinus thrombosis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tremor
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Trigeminal neuralgia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Unresponsive to stimuli
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VIth nerve paralysis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral artery dissection
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral artery thrombosis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebrobasilar insufficiency
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vocal cord paralysis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Abdominal lymphadenopathy
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia
|
|
|
subjects affected / exposed
|
19 / 5992 (0.32%) |
12 / 5995 (0.20%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia macrocytic
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Autoimmune haemolytic anaemia
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Disseminated intravascular coagulation
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Febrile neutropenia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic anaemia
|
|
|
subjects affected / exposed
|
7 / 5992 (0.12%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iron deficiency anaemia
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukopenia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenopathy
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Microcytic anaemia
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normochromic normocytic anaemia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic haematoma
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic infarction
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spontaneous haematoma
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
Tympanic membrane perforation
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo
|
|
|
subjects affected / exposed
|
8 / 5992 (0.13%) |
9 / 5995 (0.15%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Cataract
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Charles Bonnet syndrome
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deformity of orbit
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular oedema
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oscillopsia
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal artery occlusion
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal vascular thrombosis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous adhesions
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous haemorrhage
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Abdominal adhesions
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal discomfort
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal fat apron
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal hernia
|
|
|
subjects affected / exposed
|
10 / 5992 (0.17%) |
7 / 5995 (0.12%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal hernia obstructive
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal incarcerated hernia
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
subjects affected / exposed
|
11 / 5992 (0.18%) |
9 / 5995 (0.15%) |
occurrences causally related to treatment / all
|
1 / 11 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
subjects affected / exposed
|
7 / 5992 (0.12%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall haematoma
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal incontinence
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anorectal varices
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ascites
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coeliac artery stenosis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
subjects affected / exposed
|
8 / 5992 (0.13%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis microscopic
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ulcerative
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colonic pseudo-obstruction
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
6 / 5992 (0.10%) |
8 / 5995 (0.13%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Crohn's disease
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
subjects affected / exposed
|
6 / 5992 (0.10%) |
8 / 5995 (0.13%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dieulafoy's vascular malformation
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticular perforation
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer perforation
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenitis
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenogastric reflux
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
subjects affected / exposed
|
6 / 5992 (0.10%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocele
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erosive duodenitis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erosive oesophagitis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Faecaloma
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Food poisoning
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric antral vascular ectasia
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric disorder
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric haemorrhage
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gastric perforation
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric polyps
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
subjects affected / exposed
|
5 / 5992 (0.08%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
6 / 5992 (0.10%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal angiodysplasia haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
27 / 5992 (0.45%) |
29 / 5995 (0.48%) |
occurrences causally related to treatment / all
|
0 / 30 |
0 / 29 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Gastrointestinal necrosis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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 / 5992 (0.02%) |
0 / 5995 (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
|
9 / 5992 (0.15%) |
11 / 5995 (0.18%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematochezia
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
subjects affected / exposed
|
5 / 5992 (0.08%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired gastric emptying
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated umbilical hernia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
subjects affected / exposed
|
9 / 5992 (0.15%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal dilatation
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal ischaemia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
7 / 5995 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intra-abdominal haematoma
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Irritable bowel syndrome
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
9 / 5992 (0.15%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Megacolon
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melaena
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric artery stenosis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric panniculitis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nausea
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
8 / 5995 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstruction gastric
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Odynophagia
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal food impaction
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal pain
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal spasm
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal stenosis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal varices haemorrhage
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Omental infarction
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
14 / 5992 (0.23%) |
13 / 5995 (0.22%) |
occurrences causally related to treatment / all
|
5 / 15 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
subjects affected / exposed
|
15 / 5992 (0.25%) |
9 / 5995 (0.15%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pancreatitis chronic
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis relapsing
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer haemorrhage
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
6 / 5992 (0.10%) |
8 / 5995 (0.13%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal polyp
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland mass
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
subjects affected / exposed
|
18 / 5992 (0.30%) |
11 / 5995 (0.18%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tongue disorder
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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 / 5992 (0.12%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
5 / 5992 (0.08%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uvulitis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visceroptosis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vomiting
|
|
|
subjects affected / exposed
|
7 / 5992 (0.12%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Angioedema
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decubitus ulcer
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis atopic
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ulcer
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug reaction with eosinophilia and systemic symptoms
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Excessive skin
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperhidrosis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypersensitivity vasculitis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutrophilic dermatosis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Petechiae
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pruritus
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash erythematous
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
subjects affected / exposed
|
5 / 5992 (0.08%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Telangiectasia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
Acute kidney injury
|
|
|
subjects affected / exposed
|
57 / 5992 (0.95%) |
57 / 5995 (0.95%) |
occurrences causally related to treatment / all
|
1 / 64 |
0 / 61 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Acute prerenal failure
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Albuminuria
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Azotaemia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder disorder
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder dysfunction
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neck obstruction
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder necrosis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder outlet obstruction
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder prolapse
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder stenosis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus urinary
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
subjects affected / exposed
|
5 / 5992 (0.08%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cystitis haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic nephropathy
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
End stage renal disease
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematuria
|
|
|
subjects affected / exposed
|
7 / 5992 (0.12%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage urinary tract
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower urinary tract symptoms
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
18 / 5992 (0.30%) |
11 / 5995 (0.18%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive uropathy
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oliguria
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Proteinuria
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery stenosis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal colic
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Renal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal infarct
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal mass
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteral disorder
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureterocele
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureterolithiasis
|
|
|
subjects affected / exposed
|
6 / 5992 (0.10%) |
7 / 5995 (0.12%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary bladder haemorrhage
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
subjects affected / exposed
|
6 / 5992 (0.10%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Adrenal insufficiency
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Goitre
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperparathyroidism
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperthyroidism
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypothyroidism
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid mass
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyrotoxic crisis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
25 / 5992 (0.42%) |
25 / 5995 (0.42%) |
occurrences causally related to treatment / all
|
0 / 26 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis
|
|
|
subjects affected / exposed
|
16 / 5992 (0.27%) |
19 / 5995 (0.32%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis reactive
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthropathy
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back pain
|
|
|
subjects affected / exposed
|
15 / 5992 (0.25%) |
16 / 5995 (0.27%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical spinal stenosis
|
|
|
subjects affected / exposed
|
8 / 5992 (0.13%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondrocalcinosis pyrophosphate
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Costochondritis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Exostosis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibromyalgia
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Flank pain
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot deformity
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture delayed union
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture malunion
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture nonunion
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gouty arthritis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemarthrosis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc compression
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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
|
5 / 5992 (0.08%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc displacement
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
15 / 5992 (0.25%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc space narrowing
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb discomfort
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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
|
13 / 5992 (0.22%) |
12 / 5995 (0.20%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mobility decreased
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Monarthritis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle spasms
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
13 / 5992 (0.22%) |
10 / 5995 (0.17%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
subjects affected / exposed
|
7 / 5992 (0.12%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myalgia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myositis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neck mass
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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
|
3 / 5992 (0.05%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathic arthropathy
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
subjects affected / exposed
|
109 / 5992 (1.82%) |
93 / 5995 (1.55%) |
occurrences causally related to treatment / all
|
0 / 121 |
0 / 97 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoarthropathy
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteolysis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoporosis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in jaw
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pathological fracture
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plantar fasciitis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyarthritis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polymyalgia rheumatica
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rheumatoid arthritis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
subjects affected / exposed
|
10 / 5992 (0.17%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scoliosis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue mass
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal column stenosis
|
|
|
subjects affected / exposed
|
10 / 5992 (0.17%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
subjects affected / exposed
|
7 / 5992 (0.12%) |
10 / 5995 (0.17%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal pain
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylitis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
subjects affected / exposed
|
5 / 5992 (0.08%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Synovial cyst
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral osteophyte
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Abdominal abscess
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall abscess
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess neck
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess of salivary gland
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute sinusitis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
subjects affected / exposed
|
9 / 5992 (0.15%) |
9 / 5995 (0.15%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis perforated
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis infective
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
subjects affected / exposed
|
6 / 5992 (0.10%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial infection
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial sepsis
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone abscess
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchiolitis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
26 / 5992 (0.43%) |
18 / 5995 (0.30%) |
occurrences causally related to treatment / all
|
0 / 26 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis viral
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Campylobacter infection
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Campylobacter sepsis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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 / 5992 (0.02%) |
0 / 5995 (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
|
71 / 5992 (1.18%) |
48 / 5995 (0.80%) |
occurrences causally related to treatment / all
|
0 / 81 |
2 / 52 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis pasteurella
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis staphylococcal
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis streptococcal
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis infective
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic sinusitis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic tonsillitis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile infection
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colonic abscess
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dengue fever
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related infection
|
|
|
subjects affected / exposed
|
7 / 5992 (0.12%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related sepsis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot infection
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gangrene
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea infectious
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
subjects affected / exposed
|
17 / 5992 (0.28%) |
23 / 5995 (0.38%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Emphysematous cystitis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Empyema
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalitis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterococcal bacteraemia
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epididymitis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia bacteraemia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia infection
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extradural abscess
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gangrene
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
13 / 5992 (0.22%) |
10 / 5995 (0.17%) |
occurrences causally related to treatment / all
|
0 / 13 |
1 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis bacterial
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
7 / 5995 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin abscess
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin infection
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
H1N1 influenza
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis A
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Human anaplasmosis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Human ehrlichiosis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incision site abscess
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incision site infection
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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
|
3 / 5992 (0.05%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infectious colitis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infectious pleural effusion
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Infective exacerbation of chronic obstructive airways disease
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective tenosynovitis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza
|
|
|
subjects affected / exposed
|
10 / 5992 (0.17%) |
12 / 5995 (0.20%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kidney infection
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Klebsiella bacteraemia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Labyrinthitis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngitis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Localised infection
|
|
|
subjects affected / exposed
|
5 / 5992 (0.08%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower respiratory tract infection viral
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lyme disease
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphangitis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mastoiditis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrotising fasciitis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenic sepsis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal candidiasis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orchitis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
subjects affected / exposed
|
13 / 5992 (0.22%) |
11 / 5995 (0.18%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis acute
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parainfluenzae virus infection
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraspinal abscess
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic abscess
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perirectal abscess
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis bacterial
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal abscess
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngitis
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
subjects affected / exposed
|
86 / 5992 (1.44%) |
92 / 5995 (1.53%) |
occurrences causally related to treatment / all
|
1 / 90 |
0 / 105 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
Pneumonia bacterial
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia legionella
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia mycoplasmal
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia pneumococcal
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia staphylococcal
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia streptococcal
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (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
|
4 / 5992 (0.07%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural cellulitis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative abscess
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulmonary sepsis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory moniliasis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory syncytial virus infection
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection viral
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rocky mountain spotted fever
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rotavirus infection
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scrotal abscess
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sepsis
|
|
|
subjects affected / exposed
|
27 / 5992 (0.45%) |
37 / 5995 (0.62%) |
occurrences causally related to treatment / all
|
0 / 27 |
0 / 39 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 4 |
Sepsis syndrome
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Septic arthritis staphylococcal
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Septic embolus
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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
|
5 / 5992 (0.08%) |
7 / 5995 (0.12%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Sialoadenitis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinusitis
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal bacteraemia
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal infection
|
|
|
subjects affected / exposed
|
3 / 5992 (0.05%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal osteomyelitis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal skin infection
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcal bacteraemia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcal infection
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous abscess
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsillitis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth abscess
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth infection
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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 / 5992 (0.05%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
40 / 5992 (0.67%) |
30 / 5995 (0.50%) |
occurrences causally related to treatment / all
|
2 / 41 |
0 / 30 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection bacterial
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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 enterococcal
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
subjects affected / exposed
|
7 / 5992 (0.12%) |
13 / 5995 (0.22%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent infection
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral infection
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral upper respiratory tract infection
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulvitis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
West Nile viral infection
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
2 / 5995 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound abscess
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
0 / 5995 (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
|
4 / 5992 (0.07%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection pseudomonas
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection staphylococcal
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholesterosis
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decreased appetite
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dehydration
|
|
|
subjects affected / exposed
|
21 / 5992 (0.35%) |
13 / 5995 (0.22%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
subjects affected / exposed
|
13 / 5992 (0.22%) |
11 / 5995 (0.18%) |
occurrences causally related to treatment / all
|
0 / 13 |
1 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus inadequate control
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Electrolyte imbalance
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fluid overload
|
|
|
subjects affected / exposed
|
5 / 5992 (0.08%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gout
|
|
|
subjects affected / exposed
|
6 / 5992 (0.10%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
subjects affected / exposed
|
11 / 5992 (0.18%) |
6 / 5995 (0.10%) |
occurrences causally related to treatment / all
|
1 / 11 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hyperosmolar hyperglycaemic state
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
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
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperphosphataemia
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypocalcaemia
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
7 / 5992 (0.12%) |
18 / 5995 (0.30%) |
occurrences causally related to treatment / all
|
1 / 7 |
3 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
5 / 5992 (0.08%) |
10 / 5995 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypomagnesaemia
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
4 / 5995 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
4 / 5992 (0.07%) |
5 / 5995 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypophagia
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
3 / 5995 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lactic acidosis
|
|
|
subjects affected / exposed
|
1 / 5992 (0.02%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic acidosis
|
|
|
subjects affected / exposed
|
2 / 5992 (0.03%) |
0 / 5995 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obesity
|
|
|
subjects affected / exposed
|
12 / 5992 (0.20%) |
12 / 5995 (0.20%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
subjects affected / exposed
|
11 / 5992 (0.18%) |
7 / 5995 (0.12%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitamin D deficiency
|
|
|
subjects affected / exposed
|
0 / 5992 (0.00%) |
1 / 5995 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |