Serious adverse events
|
Placebo |
Sitagliptin |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
909 / 7274 (12.50%) |
928 / 7266 (12.77%) |
number of deaths (all causes)
|
57 |
54 |
number of deaths resulting from adverse events
|
3 |
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Abdominal neoplasm
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute myeloid leukaemia
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma gastric
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Adenocarcinoma of appendix
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
subjects affected / exposed
|
12 / 7274 (0.16%) |
11 / 7266 (0.15%) |
occurrences causally related to treatment / all
|
1 / 12 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Adenocarcinoma of salivary gland
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma of the cervix
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma pancreas
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 2 |
Adenoid cystic carcinoma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenolymphoma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal cancer
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (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 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaplastic large-cell lymphoma
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angioimmunoblastic T-cell lymphoma
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (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
|
4 / 7274 (0.05%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
subjects affected / exposed
|
55 / 7274 (0.76%) |
44 / 7266 (0.61%) |
occurrences causally related to treatment / all
|
0 / 86 |
0 / 50 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basosquamous carcinoma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign gastric neoplasm
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign salivary gland neoplasm
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct cancer
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
3 / 7266 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Bladder cancer
|
|
|
subjects affected / exposed
|
10 / 7274 (0.14%) |
15 / 7266 (0.21%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Bladder cancer recurrent
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neoplasm
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder papilloma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
subjects affected / exposed
|
6 / 7274 (0.08%) |
6 / 7266 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Bone cancer
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone neoplasm
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone sarcoma
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bowen's disease
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
4 / 7266 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer
|
|
|
subjects affected / exposed
|
5 / 7274 (0.07%) |
5 / 7266 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer in situ
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer recurrent
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchial carcinoma
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
3 / 7266 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Carcinoid tumour of the small bowel
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carcinoid tumour pulmonary
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Central nervous system lymphoma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cervix carcinoma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangiocarcinoma
|
|
|
subjects affected / exposed
|
4 / 7274 (0.05%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Cholesteatoma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic lymphocytic leukaemia
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
4 / 7266 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Chronic lymphocytic leukaemia recurrent
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic myeloid leukaemia
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Clear cell renal cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Colon adenoma
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
4 / 7266 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
subjects affected / exposed
|
14 / 7274 (0.19%) |
11 / 7266 (0.15%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 0 |
Colon cancer metastatic
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer stage I
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer stage IV
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon neoplasm
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal adenocarcinoma
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Colorectal cancer
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diffuse large B-cell lymphoma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Endometrial adenocarcinoma
|
|
|
subjects affected / exposed
|
5 / 7274 (0.07%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial cancer
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder cancer
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric adenoma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric cancer
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
5 / 7266 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gastric cancer recurrent
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gastric cancer stage IV
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal carcinoma
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal tract adenoma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glioblastoma multiforme
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Glioma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cancer
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Hepatic cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatic neoplasm
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatocellular carcinoma
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Intraductal papilloma of breast
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (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
|
2 / 7274 (0.03%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraocular melanoma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive ductal breast carcinoma
|
|
|
subjects affected / exposed
|
4 / 7274 (0.05%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
1 / 4 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Laryngeal cancer
|
|
|
subjects affected / exposed
|
4 / 7274 (0.05%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leiomyosarcoma
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leiomyosarcoma metastatic
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lentigo maligna
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukaemia
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lip and/or oral cavity cancer
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lip squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lipoma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
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
|
4 / 7274 (0.05%) |
6 / 7266 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Lung adenocarcinoma metastatic
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lung adenocarcinoma stage I
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma stage IV
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung cancer metastatic
|
|
|
subjects affected / exposed
|
4 / 7274 (0.05%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Lung carcinoma cell type unspecified stage IV
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
3 / 7266 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Lung neoplasm
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung neoplasm malignant
|
|
|
subjects affected / exposed
|
12 / 7274 (0.16%) |
12 / 7266 (0.17%) |
occurrences causally related to treatment / all
|
1 / 12 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 3 |
Lung squamous cell carcinoma stage III
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lymphocytic leukaemia
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Malignant melanoma
|
|
|
subjects affected / exposed
|
6 / 7274 (0.08%) |
10 / 7266 (0.14%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Malignant melanoma in situ
|
|
|
subjects affected / exposed
|
4 / 7274 (0.05%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant neoplasm of ampulla of Vater
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant neoplasm of renal pelvis
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melanocytic naevus
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningeal neoplasm
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (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 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningioma malignant
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to bone
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastases to central nervous system
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Metastases to liver
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to spine
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastatic bronchial carcinoma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastatic malignant melanoma
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastatic renal cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic uterine cancer
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mucinous adenocarcinoma of appendix
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelodysplastic syndrome
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
3 / 7266 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Nasal cavity cancer
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasopharyngeal cancer
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm recurrence
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroendocrine carcinoma metastatic
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
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
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurofibroma
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (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
|
1 / 7274 (0.01%) |
6 / 7266 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Non-small cell lung cancer
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-small cell lung cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Oesophageal adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Oesophageal carcinoma
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Oesophageal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oropharyngeal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ovarian adenoma
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cancer
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (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 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ovarian germ cell teratoma benign
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian granulosa-theca cell tumour
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian neoplasm
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic carcinoma
|
|
|
subjects affected / exposed
|
7 / 7274 (0.10%) |
8 / 7266 (0.11%) |
occurrences causally related to treatment / all
|
2 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
2 / 6 |
0 / 4 |
Pancreatic carcinoma metastatic
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Papillary thyroid cancer
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parathyroid tumour benign
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Penile cancer
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Penile squamous cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phaeochromocytoma
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pituitary tumour
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pituitary tumour benign
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
subjects affected / exposed
|
6 / 7274 (0.08%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Plasmablastic lymphoma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasmacytoma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleomorphic liposarcoma
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural mesothelioma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Polycythaemia vera
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
subjects affected / exposed
|
45 / 7274 (0.62%) |
36 / 7266 (0.50%) |
occurrences causally related to treatment / all
|
0 / 45 |
0 / 36 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Prostate cancer metastatic
|
|
|
subjects affected / exposed
|
5 / 7274 (0.07%) |
5 / 7266 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
Prostate cancer recurrent
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
3 / 7266 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer stage I
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic adenoma
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Rectal cancer
|
|
|
subjects affected / exposed
|
4 / 7274 (0.05%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectosigmoid cancer
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Renal cancer
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
7 / 7266 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (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
|
2 / 7274 (0.03%) |
3 / 7266 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cell carcinoma recurrent
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cell carcinoma stage I
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cell carcinoma stage III
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal neoplasm
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal oncocytoma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal cancer
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sarcoma
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin cancer
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Small cell lung cancer
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Squamous cell carcinoma
|
|
|
subjects affected / exposed
|
38 / 7274 (0.52%) |
26 / 7266 (0.36%) |
occurrences causally related to treatment / all
|
0 / 44 |
0 / 38 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Squamous cell carcinoma of head and neck
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (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 lung
|
|
|
subjects affected / exposed
|
7 / 7274 (0.10%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Squamous cell carcinoma of skin
|
|
|
subjects affected / exposed
|
20 / 7274 (0.27%) |
12 / 7266 (0.17%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the oral cavity
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the tongue
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
T-cell lymphoma
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
T-cell prolymphocytic leukaemia
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Testis cancer
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thymic cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid adenoma
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid cancer
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tongue cancer recurrent
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tongue neoplasm malignant stage unspecified
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (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 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsil cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Tracheal cancer
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheal neoplasm
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transitional cell carcinoma
|
|
|
subjects affected / exposed
|
7 / 7274 (0.10%) |
7 / 7266 (0.10%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Urethral neoplasm
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine cancer
|
|
|
subjects affected / exposed
|
4 / 7274 (0.05%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Uterine leiomyoma
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Angiodysplasia
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic dissection
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic stenosis
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial haemorrhage
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bleeding varicose vein
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral artery aneurysm
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (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
|
2 / 7274 (0.03%) |
6 / 7266 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotension
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intra-abdominal haematoma
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphocele
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphoedema
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphorrhoea
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Temporal arteritis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose vein
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (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 / 7274 (0.01%) |
3 / 7266 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthenia
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest pain
|
|
|
subjects affected / exposed
|
8 / 7274 (0.11%) |
6 / 7266 (0.08%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device dislocation
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device malfunction
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug intolerance
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fat necrosis
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (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 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
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 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Granuloma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hernia
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malaise
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mucosal hyperaemia
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multi-organ failure
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
26 / 7274 (0.36%) |
17 / 7266 (0.23%) |
occurrences causally related to treatment / all
|
0 / 31 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Puncture site haemorrhage
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal pain
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Submandibular mass
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
Corneal graft rejection
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
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
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Atrophic vulvovaginitis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
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
|
11 / 7274 (0.15%) |
15 / 7266 (0.21%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus prostatic
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical polyp
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epididymal cyst
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
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 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Genital rash
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metrorrhagia
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
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 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cyst
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic floor muscle weakness
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postmenopausal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic obstruction
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatism
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatomegaly
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
4 / 7266 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine polyp
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterovaginal prolapse
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Acute pulmonary oedema
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute respiratory distress syndrome
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute respiratory failure
|
|
|
subjects affected / exposed
|
5 / 7274 (0.07%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alveolitis
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alveolitis allergic
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthma
|
|
|
subjects affected / exposed
|
4 / 7274 (0.05%) |
8 / 7266 (0.11%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atelectasis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
30 / 7274 (0.41%) |
13 / 7266 (0.18%) |
occurrences causally related to treatment / all
|
0 / 37 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Chronic respiratory disease
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cough
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Emphysema
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
subjects affected / exposed
|
6 / 7274 (0.08%) |
9 / 7266 (0.12%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemothorax
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrothorax
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperventilation
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Idiopathic pulmonary fibrosis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal cyst
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Nasal obstruction
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal polyps
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthopnoea
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
4 / 7266 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleuritic pain
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
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 / 7274 (0.05%) |
3 / 7266 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Productive cough
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary alveolar haemorrhage
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary arterial hypertension
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
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
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary fibrosis
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pulmonary hypertension
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
3 / 7266 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory distress
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
4 / 7266 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Sinus polyp
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sleep apnoea syndrome
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stridor
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheal disorder
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Alcohol abuse
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delirium
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
4 / 7266 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dissociative disorder
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug abuse
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug dependence
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Major depression
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nicotine dependence
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paranoid personality disorder
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
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
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicide attempt
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Anticoagulation drug level increased
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
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
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic enzyme abnormal
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
International normalised ratio increased
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic specific antigen increased
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
White blood cell count increased
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
Abdominal wound dehiscence
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Accidental overdose
|
|
|
subjects affected / exposed
|
19 / 7274 (0.26%) |
17 / 7266 (0.23%) |
occurrences causally related to treatment / all
|
15 / 19 |
13 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acetabulum fracture
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol poisoning
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (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
|
3 / 7274 (0.04%) |
6 / 7266 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthropod bite
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthropod sting
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Avulsion fracture
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain contusion
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
3 / 7266 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Burns second degree
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Burns third degree
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical vertebral fracture
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chemical burns of eye
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Comminuted fracture
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Concussion
|
|
|
subjects affected / exposed
|
4 / 7274 (0.05%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Contusion
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
3 / 7266 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Delayed recovery from anaesthesia
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dislocation of vertebra
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
subjects affected / exposed
|
4 / 7274 (0.05%) |
3 / 7266 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
subjects affected / exposed
|
9 / 7274 (0.12%) |
9 / 7266 (0.12%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
5 / 7266 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Femur fracture
|
|
|
subjects affected / exposed
|
11 / 7274 (0.15%) |
7 / 7266 (0.10%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
3 / 7266 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
4 / 7266 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Forearm fracture
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foreign body
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture displacement
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal stoma complication
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (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 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head injury
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
5 / 7266 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heat stroke
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
subjects affected / exposed
|
6 / 7274 (0.08%) |
5 / 7266 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Humerus fracture
|
|
|
subjects affected / exposed
|
9 / 7274 (0.12%) |
4 / 7266 (0.06%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intentional overdose
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laceration
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
4 / 7266 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament injury
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament rupture
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
3 / 7266 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament sprain
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb traumatic amputation
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
4 / 7266 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
3 / 7266 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mouth injury
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle injury
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Near drowning
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Overdose
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Patella fracture
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periorbital haematoma
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periprosthetic fracture
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periprosthetic osteolysis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural fistula
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative ileus
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (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 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prescribed overdose
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural complication
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pubis fracture
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary contusion
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
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
|
3 / 7274 (0.04%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal haematoma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
subjects affected / exposed
|
5 / 7274 (0.07%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
5 / 7266 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skull fracture
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue injury
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal column injury
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
subjects affected / exposed
|
4 / 7274 (0.05%) |
5 / 7266 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Splinter
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sternal fracture
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
subjects affected / exposed
|
4 / 7274 (0.05%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Subdural haemorrhage
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Tendon rupture
|
|
|
subjects affected / exposed
|
5 / 7274 (0.07%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Testicular injury
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thermal burn
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tongue injury
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
5 / 7266 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheal injury
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic intracranial haemorrhage
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulnar nerve injury
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary bladder rupture
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
4 / 7266 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
Arteriovenous malformation
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hamartoma
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocele
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phimosis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyloric stenosis
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Syringomyelia
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitello-intestinal duct remnant
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Angina pectoris
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cor pulmonale
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery thrombosis
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Palpitations
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus arrhythmia
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
Acoustic neuritis
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arachnoid cyst
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ataxia
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal ganglia haemorrhage
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain injury
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cauda equina syndrome
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Central nervous system lesion
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical cord compression
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical myelopathy
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical radiculopathy
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervicobrachial syndrome
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cognitive disorder
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complex partial seizures
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Convulsion
|
|
|
subjects affected / exposed
|
6 / 7274 (0.08%) |
5 / 7266 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cubital tunnel syndrome
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
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 / 7274 (0.03%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia Alzheimer's type
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
7 / 7266 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness postural
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial paresis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Headache
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypersomnia
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracranial aneurysm
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar radiculopathy
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
3 / 7266 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Migraine
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Monoplegia
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myasthenia gravis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myasthenia gravis crisis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelopathy
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve compression
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve root compression
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorder
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuralgia
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurological symptom
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normal pressure hydrocephalus
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parkinson's disease
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Partial seizures
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral sensorimotor neuropathy
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Petit mal epilepsy
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Piriformis syndrome
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Posterior reversible encephalopathy syndrome
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postictal state
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiculitis lumbosacral
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retrograde amnesia
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sciatica
|
|
|
subjects affected / exposed
|
4 / 7274 (0.05%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sensory disturbance
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal cord disorder
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural effusion
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (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
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thoracic outlet syndrome
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulnar tunnel syndrome
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular dementia
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebrobasilar insufficiency
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo CNS origin
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
subjects affected / exposed
|
23 / 7274 (0.32%) |
23 / 7266 (0.32%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia vitamin B12 deficiency
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Autoimmune haemolytic anaemia
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemolytic anaemia
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic anaemia
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iron deficiency anaemia
|
|
|
subjects affected / exposed
|
6 / 7274 (0.08%) |
6 / 7266 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenopathy mediastinal
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Microcytic anaemia
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
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
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pernicious anaemia
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
Deafness bilateral
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoacusis
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniere's disease
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden hearing loss
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tinnitus
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
4 / 7266 (0.06%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo labyrinthine
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
3 / 7266 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular disorder
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Amaurosis fugax
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angle closure glaucoma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Corneal degeneration
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dacryostenosis acquired
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Optic ischaemic neuropathy
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual acuity reduced
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous haemorrhage
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (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 discomfort
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal hernia
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal hernia obstructive
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
4 / 7266 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall haematoma
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abnormal faeces
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fissure
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fistula
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ascites
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Change of bowel habit
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colonic fistula
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colonic pseudo-obstruction
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Constipation
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
4 / 7266 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Crohn's disease
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diaphragmatic hernia
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticular perforation
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal polyp
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
5 / 7266 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenitis
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterovesical fistula
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erosive oesophagitis
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (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
|
2 / 7274 (0.03%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric polyps
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
subjects affected / exposed
|
4 / 7274 (0.05%) |
3 / 7266 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
10 / 7266 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
subjects affected / exposed
|
4 / 7274 (0.05%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroduodenal ulcer
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroduodenitis haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
12 / 7274 (0.16%) |
11 / 7266 (0.15%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal necrosis
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal ulcer
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (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 / 7274 (0.01%) |
0 / 7266 (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
|
0 / 7274 (0.00%) |
9 / 7266 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematochezia
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
subjects affected / exposed
|
5 / 7274 (0.07%) |
4 / 7266 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus paralytic
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
subjects affected / exposed
|
11 / 7274 (0.15%) |
12 / 7266 (0.17%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia, obstructive
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
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 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal ischaemia
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal polyp
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intussusception
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jejunal perforation
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestinal stenosis
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
6 / 7266 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mallory-Weiss syndrome
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melaena
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstruction gastric
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema mouth
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal achalasia
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal food impaction
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal motility disorder
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal spasm
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal varices haemorrhage
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic pseudocyst
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer perforation
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periodontal disease
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngo-oesophageal diverticulum
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (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
|
3 / 7274 (0.04%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal polyp
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal prolapse
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland calculus
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
subjects affected / exposed
|
6 / 7274 (0.08%) |
8 / 7266 (0.11%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal perforation
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tongue disorder
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
4 / 7266 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
6 / 7274 (0.08%) |
3 / 7266 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Varices oesophageal
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Volvulus
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Bile duct stone
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary colic
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary dyskinesia
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug-induced liver injury
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder polyp
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cirrhosis
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic congestion
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cyst
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic failure
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic function abnormal
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis acute
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis toxic
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Angioedema
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decubitus ulcer
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis contact
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis psoriasiform
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eczema asteatotic
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkeratosis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lichen sclerosus
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pemphigoid
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pruritus
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
Bladder outlet obstruction
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (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 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus bladder
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus ureteric
|
|
|
subjects affected / exposed
|
6 / 7274 (0.08%) |
6 / 7266 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus urinary
|
|
|
subjects affected / exposed
|
4 / 7274 (0.05%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematuria
|
|
|
subjects affected / exposed
|
6 / 7274 (0.08%) |
6 / 7266 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
3 / 7266 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
9 / 7274 (0.12%) |
10 / 7266 (0.14%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery stenosis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal colic
|
|
|
subjects affected / exposed
|
4 / 7274 (0.05%) |
4 / 7266 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cyst
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure acute
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal tubular necrosis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stag horn calculus
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tubulointerstitial nephritis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric obstruction
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
subjects affected / exposed
|
4 / 7274 (0.05%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary bladder polyp
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary incontinence
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
subjects affected / exposed
|
6 / 7274 (0.08%) |
4 / 7266 (0.06%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Adrenocortical insufficiency acute
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Goitre
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperthyroidism
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypothyroidism
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inappropriate antidiuretic hormone secretion
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Ankle impingement
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthralgia
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis reactive
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthropathy
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back pain
|
|
|
subjects affected / exposed
|
4 / 7274 (0.05%) |
6 / 7266 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondrocalcinosis
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Compartment syndrome
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dupuytren's contracture
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gouty arthritis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemarthrosis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc compression
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc disorder
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc displacement
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
8 / 7274 (0.11%) |
8 / 7266 (0.11%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint effusion
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint swelling
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
subjects affected / exposed
|
5 / 7274 (0.07%) |
13 / 7266 (0.18%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
6 / 7274 (0.08%) |
5 / 7266 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myalgia
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteitis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
subjects affected / exposed
|
35 / 7274 (0.48%) |
52 / 7266 (0.72%) |
occurrences causally related to treatment / all
|
0 / 37 |
0 / 54 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteochondrosis
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoporosis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polymyalgia rheumatica
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psoriatic arthropathy
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rheumatoid arthritis
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
subjects affected / exposed
|
7 / 7274 (0.10%) |
6 / 7266 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal column stenosis
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
4 / 7266 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
subjects affected / exposed
|
5 / 7274 (0.07%) |
7 / 7266 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Synovial cyst
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tenosynovitis
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tenosynovitis stenosans
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Trigger finger
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Abdominal abscess
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute hepatitis B
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis perforated
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
subjects affected / exposed
|
4 / 7274 (0.05%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis infective
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dengue fever
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
subjects affected / exposed
|
4 / 7274 (0.05%) |
6 / 7266 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
3 / 7266 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis C
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
3 / 7266 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis E
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes simplex encephalitis
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (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 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected bites
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective exacerbation of chronic obstructive airways disease
|
|
|
subjects affected / exposed
|
3 / 7274 (0.04%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngitis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver abscess
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lyme disease
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mycetoma mycotic
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal candidiasis
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis media
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis media chronic
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary tuberculosis
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (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
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scrub typhus
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sepsis
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sialoadenitis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinusitis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth abscess
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Typhoid fever
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral infection
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Decreased appetite
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dehydration
|
|
|
subjects affected / exposed
|
8 / 7274 (0.11%) |
5 / 7266 (0.07%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrolyte imbalance
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Failure to thrive
|
|
|
subjects affected / exposed
|
2 / 7274 (0.03%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
subjects affected / exposed
|
5 / 7274 (0.07%) |
8 / 7266 (0.11%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoalbuminaemia
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypochloraemia
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
2 / 7266 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
4 / 7274 (0.05%) |
3 / 7266 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
21 / 7274 (0.29%) |
8 / 7266 (0.11%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypophagia
|
|
|
subjects affected / exposed
|
0 / 7274 (0.00%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypophosphataemia
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
0 / 7266 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obesity
|
|
|
subjects affected / exposed
|
1 / 7274 (0.01%) |
1 / 7266 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |