Serious adverse events
|
Placebo |
Denosumab |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
675 / 2218 (30.43%) |
702 / 2241 (31.33%) |
number of deaths (all causes)
|
215 |
215 |
number of deaths resulting from adverse events
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Acrochordon
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute leukaemia
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute myeloid leukaemia
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Adenocarcinoma gastric
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenolipoma
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendix cancer
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
B-cell lymphoma
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
B-cell small lymphocytic lymphoma
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
4 / 2241 (0.18%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of thymus
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of thyroid gland
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
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
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma stage III
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
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
|
1 / 2218 (0.05%) |
0 / 2241 (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
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
8 / 2241 (0.36%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Breast cancer metastatic
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
4 / 2241 (0.18%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Breast cancer recurrent
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cancer pain
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest wall tumour
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (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
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
subjects affected / exposed
|
5 / 2218 (0.23%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Colorectal adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial adenoma
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial cancer
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial cancer stage I
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial stromal sarcoma
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extranodal marginal zone B-cell lymphoma (MALT type)
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fallopian tube cancer
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric cancer
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gastric neoplasm
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cancer
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatocellular carcinoma
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal metastasis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraductal proliferative breast lesion
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive ductal breast carcinoma
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine benign neoplasm
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leiomyoma
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leiomyosarcoma
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leiomyosarcoma metastatic
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Lung adenocarcinoma stage IV
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lung cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung neoplasm malignant
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphangiosis carcinomatosa
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma stage III
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant neoplasm of thorax
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Malignant neoplasm progression
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant pleural effusion
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningioma
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to bone
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to breast
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to central nervous system
|
|
|
subjects affected / exposed
|
17 / 2218 (0.77%) |
15 / 2241 (0.67%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 4 |
Metastases to liver
|
|
|
subjects affected / exposed
|
4 / 2218 (0.18%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to lung
|
|
|
subjects affected / exposed
|
4 / 2218 (0.18%) |
7 / 2241 (0.31%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastases to lymph nodes
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to meninges
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Metastases to ovary
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to peritoneum
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastases to skin
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic neoplasm
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroendocrine carcinoma
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-small cell lung cancer stage I
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal neoplasm
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian adenoma
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cancer
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cancer stage III
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ovarian epithelial cancer
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian neoplasm
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paget's disease of the vulva
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papillary thyroid cancer
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraneoplastic syndrome
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Parathyroid tumour benign
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal cancer
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cancer stage I
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retro-orbital neoplasm
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestine carcinoma
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the cervix
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thymoma
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid cancer
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid neoplasm
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
subjects affected / exposed
|
5 / 2218 (0.23%) |
5 / 2241 (0.22%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Astrocytoma
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papilloma
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Aortic stenosis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteritis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brachiocephalic vein thrombosis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
12 / 2218 (0.54%) |
9 / 2241 (0.40%) |
occurrences causally related to treatment / all
|
0 / 12 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism arterial
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism venous
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertension
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotension
|
|
|
subjects affected / exposed
|
6 / 2218 (0.27%) |
7 / 2241 (0.31%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intermittent claudication
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphocele
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphoedema
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
5 / 2241 (0.22%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral vascular disorder
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phlebitis
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shock
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian artery thrombosis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian vein thrombosis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Superior vena cava syndrome
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis superficial
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose vein
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vena cava thrombosis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
Ankle arthroplasty
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast conserving surgery
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast operation
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast reconstruction
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cancer surgery
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter removal
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical polypectomy
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystectomy
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hysterectomy
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incisional drainage
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mammoplasty
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oophorectomy bilateral
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salpingo-oophorectomy bilateral
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine dilation and curettage
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mastectomy
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pregnancy, puerperium and perinatal conditions
|
|
|
Foetal death
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
Adverse drug reaction
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Application site pain
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthenia
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BRCA2 gene mutation
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast complication associated with device
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Capsular contracture associated with breast implant
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter site haematoma
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest discomfort
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest pain
|
|
|
subjects affected / exposed
|
6 / 2218 (0.27%) |
5 / 2241 (0.22%) |
occurrences causally related to treatment / all
|
2 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chills
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complication associated with device
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Death
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Disease progression
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Drug intolerance
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extravasation
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fatigue
|
|
|
subjects affected / exposed
|
4 / 2218 (0.18%) |
4 / 2241 (0.18%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
1 / 3 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Generalised oedema
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
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 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Idiosyncratic drug reaction
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated hernia
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inflammation
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza like illness
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infusion site extravasation
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
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 / 2218 (0.05%) |
7 / 2241 (0.31%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mucosal inflammation
|
|
|
subjects affected / exposed
|
4 / 2218 (0.18%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
4 / 2218 (0.18%) |
6 / 2241 (0.27%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral swelling
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudocyst
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
subjects affected / exposed
|
33 / 2218 (1.49%) |
37 / 2241 (1.65%) |
occurrences causally related to treatment / all
|
1 / 40 |
4 / 42 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
Drug hypersensitivity
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Allergy to vaccine
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypersensitivity
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reaction to preservatives
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Bartholin's cyst
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast haematoma
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast inflammation
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast mass
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast necrosis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast pain
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical dysplasia
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystocele
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysfunctional uterine bleeding
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial disorder
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial hyperplasia
|
|
|
subjects affected / exposed
|
4 / 2218 (0.18%) |
7 / 2241 (0.31%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometriosis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Genital haemorrhage
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Genital prolapse
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic ovarian cyst
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Menometrorrhagia
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Menopausal symptoms
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Menorrhagia
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metrorrhagia
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (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
|
7 / 2218 (0.32%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian enlargement
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic pain
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postmenopausal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine polyp
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine prolapse
|
|
|
subjects affected / exposed
|
4 / 2218 (0.18%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
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
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute respiratory distress syndrome
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Asthma
|
|
|
subjects affected / exposed
|
4 / 2218 (0.18%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atelectasis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cough
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
subjects affected / exposed
|
10 / 2218 (0.45%) |
13 / 2241 (0.58%) |
occurrences causally related to treatment / all
|
0 / 11 |
1 / 13 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Dyspnoea at rest
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea exertional
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperventilation
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
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 / 2218 (0.09%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngospasm
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung infiltration
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive airways disorder
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Organising pneumonia
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oropharyngeal pain
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
5 / 2218 (0.23%) |
4 / 2241 (0.18%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleurisy
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonitis
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
6 / 2241 (0.27%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Productive cough
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
20 / 2218 (0.90%) |
17 / 2241 (0.76%) |
occurrences causally related to treatment / all
|
0 / 21 |
2 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary mass
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory arrest
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Respiratory failure
|
|
|
subjects affected / exposed
|
7 / 2218 (0.32%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Vocal cord polyp
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Alcoholism
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (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
|
0 / 2218 (0.00%) |
7 / 2241 (0.31%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety disorder
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Confusional state
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delirium
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depressed mood
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
8 / 2241 (0.36%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypomania
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Insomnia
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Major depression
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mania
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Persistent depressive disorder
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychomotor retardation
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychotic disorder
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Restlessness
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
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
|
1 / 2218 (0.05%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product issues
|
|
|
Device expulsion
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device failure
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Bile duct stone
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
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
|
2 / 2218 (0.09%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
6 / 2241 (0.27%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
subjects affected / exposed
|
4 / 2218 (0.18%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis chronic
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
4 / 2218 (0.18%) |
5 / 2241 (0.22%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholestasis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gallbladder non-functioning
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic failure
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Hepatic function abnormal
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic steatosis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatocellular injury
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatomegaly
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperbilirubinaemia
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperplastic cholecystopathy
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaundice cholestatic
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Alanine aminotransferase increased
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aspartate aminotransferase increased
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Body temperature increased
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone scan abnormal
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac murmur
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ejection fraction decreased
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibrin D dimer increased
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoglobin decreased
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
International normalised ratio increased
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver function test abnormal
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutrophil count abnormal
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutrophil count decreased
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oestradiol increased
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oxygen saturation decreased
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stroke volume increased
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transaminases increased
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
White blood cell count decreased
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (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 / 2218 (0.00%) |
1 / 2241 (0.04%) |
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
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acetabulum fracture
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol poisoning
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cartilage injury
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (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
|
2 / 2218 (0.09%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Exposure to radiation
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
subjects affected / exposed
|
6 / 2218 (0.27%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft complication
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hand fracture
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head injury
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incision site pain
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infusion related reaction
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intentional overdose
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laceration
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament sprain
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle strain
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Overdose
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax traumatic
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Poisoning
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural complication
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural inflammation
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postmastectomy lymphoedema syndrome
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative renal failure
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative thrombosis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (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
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
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 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural pain
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pubis fracture
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiation injury
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiation mastitis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiation pneumonitis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
subjects affected / exposed
|
6 / 2218 (0.27%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scapula fracture
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seroma
|
|
|
subjects affected / exposed
|
6 / 2218 (0.27%) |
5 / 2241 (0.22%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin flap necrosis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Synovial rupture
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (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
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
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
|
2 / 2218 (0.09%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulna fracture
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
subjects affected / exposed
|
4 / 2218 (0.18%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrong drug administered
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Acute myocardial infarction
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriospasm coronary
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
6 / 2218 (0.27%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial thrombosis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac aneurysm
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure chronic
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure congestive
|
|
|
subjects affected / exposed
|
4 / 2218 (0.18%) |
4 / 2241 (0.18%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Cardiogenic shock
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiopulmonary failure
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery occlusion
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left ventricular dysfunction
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
subjects affected / exposed
|
4 / 2218 (0.18%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Palpitations
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericarditis constrictive
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus tachycardia
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachyarrhythmia
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
subjects affected / exposed
|
5 / 2218 (0.23%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular tachycardia
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
Aphasia
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ataxia
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain oedema
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar ataxia
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar infarction
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral disorder
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral infarction
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cerebral ischaemia
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrospinal fistula
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
subjects affected / exposed
|
6 / 2218 (0.27%) |
5 / 2241 (0.22%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Cervical radiculopathy
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coma hepatic
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Dementia
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia with Lewy bodies
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depressed level of consciousness
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 1 |
Dizziness
|
|
|
subjects affected / exposed
|
4 / 2218 (0.18%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dystonia
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Epilepsy
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial neuralgia
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial paralysis
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Headache
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
10 / 2241 (0.45%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocephalus
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Intracranial aneurysm
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lethargy
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Migraine
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myoclonus
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurological symptom
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Occipital neuralgia
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral sensory neuropathy
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Presyncope
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychomotor hyperactivity
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ruptured cerebral aneurysm
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sciatica
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seizure
|
|
|
subjects affected / exposed
|
4 / 2218 (0.18%) |
5 / 2241 (0.22%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Somnolence
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Status epilepticus
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Superior sagittal sinus thrombosis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Syncope
|
|
|
subjects affected / exposed
|
9 / 2218 (0.41%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombotic stroke
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
subjects affected / exposed
|
4 / 2218 (0.18%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Trigeminal nerve disorder
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual field defect
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
IIIrd nerve paralysis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (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 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Agranulocytosis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia
|
|
|
subjects affected / exposed
|
12 / 2218 (0.54%) |
17 / 2241 (0.76%) |
occurrences causally related to treatment / all
|
1 / 13 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Anaemia megaloblastic
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone marrow failure
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Febrile neutropenia
|
|
|
subjects affected / exposed
|
114 / 2218 (5.14%) |
83 / 2241 (3.70%) |
occurrences causally related to treatment / all
|
4 / 128 |
1 / 98 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune thrombocytopenic purpura
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukopenia
|
|
|
subjects affected / exposed
|
5 / 2218 (0.23%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
subjects affected / exposed
|
36 / 2218 (1.62%) |
35 / 2241 (1.56%) |
occurrences causally related to treatment / all
|
3 / 43 |
1 / 39 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
subjects affected / exposed
|
4 / 2218 (0.18%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
5 / 2218 (0.23%) |
6 / 2241 (0.27%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
Deafness
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear pain
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
External ear disorder
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
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 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
5 / 2241 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Angle closure glaucoma
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blindness
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract
|
|
|
subjects affected / exposed
|
5 / 2218 (0.23%) |
5 / 2241 (0.22%) |
occurrences causally related to treatment / all
|
3 / 5 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diplopia
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular hole
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal artery occlusion
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
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 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinopathy proliferative
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vision blurred
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous haematoma
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
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 / 2218 (0.05%) |
0 / 2241 (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 hernia
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal incarcerated hernia
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
6 / 2241 (0.27%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain lower
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fissure
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fistula
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal prolapse
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ascites
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic gastritis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
2 / 2241 (0.09%) |
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
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ulcerative
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Constipation
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
4 / 2241 (0.18%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Crohn's disease
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dental caries
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
subjects affected / exposed
|
24 / 2218 (1.08%) |
15 / 2241 (0.67%) |
occurrences causally related to treatment / all
|
0 / 25 |
2 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticular perforation
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal obstruction
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis haemorrhagic
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral hernia
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric disorder
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric polyps
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorder
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
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
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gingival pain
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoids thrombosed
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mouth ulceration
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nausea
|
|
|
subjects affected / exposed
|
10 / 2218 (0.45%) |
18 / 2241 (0.80%) |
occurrences causally related to treatment / all
|
0 / 10 |
2 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrotising colitis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Obstructive pancreatitis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal spasm
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal stenosis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis chronic
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal prolapse
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stomatitis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vomiting
|
|
|
subjects affected / exposed
|
13 / 2218 (0.59%) |
24 / 2241 (1.07%) |
occurrences causally related to treatment / all
|
0 / 14 |
2 / 31 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Angioedema
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erythema
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
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
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Onycholysis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain of skin
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash papular
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Segmented hyalinising vasculitis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic skin eruption
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urticaria
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
Acute kidney injury
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
6 / 2241 (0.27%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder perforation
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (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 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysuria
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematuria
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrocalcinosis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric stenosis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
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 / 2218 (0.05%) |
0 / 2241 (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
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Hypothyroidism
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroiditis acute
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Arthralgia
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
6 / 2241 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back pain
|
|
|
subjects affected / exposed
|
6 / 2218 (0.27%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone pain
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Flank pain
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot deformity
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
6 / 2241 (0.27%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaw disorder
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint instability
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle haemorrhage
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle spasms
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myalgia
|
|
|
subjects affected / exposed
|
4 / 2218 (0.18%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neck pain
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteitis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
subjects affected / exposed
|
4 / 2218 (0.18%) |
6 / 2241 (0.27%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteochondritis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteochondrosis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteonecrosis of jaw
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
30 / 2241 (1.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
29 / 31 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in jaw
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periarthritis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periostitis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue necrosis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Synovial cyst
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Synovitis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon disorder
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tenosynovitis stenosans
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Abdominal abscess
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendiceal abscess
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
7 / 2241 (0.31%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis perforated
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atypical pneumonia
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial sepsis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bartholinitis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast abscess
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
5 / 2241 (0.22%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cellulitis
|
|
|
subjects affected / exposed
|
18 / 2218 (0.81%) |
20 / 2241 (0.89%) |
occurrences causally related to treatment / all
|
2 / 20 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
4 / 2241 (0.18%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis infective
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Campylobacter gastroenteritis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter site infection
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
subjects affected / exposed
|
30 / 2218 (1.35%) |
34 / 2241 (1.52%) |
occurrences causally related to treatment / all
|
0 / 33 |
2 / 42 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis staphylococcal
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis streptococcal
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest wall abscess
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridial infection
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium colitis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile infection
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colonic abscess
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dengue fever
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related infection
|
|
|
subjects affected / exposed
|
10 / 2218 (0.45%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
1 / 11 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related sepsis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
subjects affected / exposed
|
8 / 2218 (0.36%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
subjects affected / exposed
|
4 / 2218 (0.18%) |
14 / 2241 (0.62%) |
occurrences causally related to treatment / all
|
1 / 5 |
1 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erysipelothrix infection
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia bacteraemia
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
4 / 2241 (0.18%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Febrile infection
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fungal skin infection
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis salmonella
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Genital herpes simplex
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
H1N1 influenza
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemophilus infection
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis B
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis C
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (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
|
2 / 2218 (0.09%) |
4 / 2241 (0.18%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected fistula
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected seroma
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infectious colitis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza
|
|
|
subjects affected / exposed
|
5 / 2218 (0.23%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral discitis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Labyrinthitis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Localised infection
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
6 / 2241 (0.27%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower respiratory tract infection bacterial
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung infection
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphangitis
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mastitis
|
|
|
subjects affected / exposed
|
8 / 2218 (0.36%) |
12 / 2241 (0.54%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mastitis bacterial
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis aseptic
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mycobacterial infection
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrotising fasciitis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenic infection
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenic sepsis
|
|
|
subjects affected / exposed
|
14 / 2218 (0.63%) |
15 / 2241 (0.67%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal candidiasis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ophthalmic herpes zoster
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oral candidiasis
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis chronic
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic inflammatory disease
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericoronitis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perirectal abscess
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal abscess
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periumbilical abscess
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal abscess
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngitis
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngitis streptococcal
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
subjects affected / exposed
|
30 / 2218 (1.35%) |
27 / 2241 (1.20%) |
occurrences causally related to treatment / all
|
0 / 32 |
2 / 29 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia bacterial
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia haemophilus
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia klebsiella
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia pneumococcal
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia staphylococcal
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia streptococcal
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural cellulitis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural infection
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative abscess
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
subjects affected / exposed
|
9 / 2218 (0.41%) |
7 / 2241 (0.31%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudomonal sepsis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (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
|
0 / 2218 (0.00%) |
5 / 2241 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
4 / 2241 (0.18%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sebaceous gland infection
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sepsis
|
|
|
subjects affected / exposed
|
11 / 2218 (0.50%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Septic shock
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Sinusitis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin infection
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal infection
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
4 / 2241 (0.18%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal skin infection
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcal sepsis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous abscess
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth abscess
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth infection
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheobronchitis
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
subjects affected / exposed
|
9 / 2218 (0.41%) |
7 / 2241 (0.31%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper respiratory tract infection bacterial
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
13 / 2218 (0.59%) |
6 / 2241 (0.27%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection bacterial
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection pseudomonal
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular neuronitis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
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
|
2 / 2218 (0.09%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral upper respiratory tract infection
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulval abscess
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulvovaginal candidiasis
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
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
|
2 / 2218 (0.09%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection bacterial
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
6 / 2241 (0.27%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection staphylococcal
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis escherichia
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Decreased appetite
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
3 / 2241 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dehydration
|
|
|
subjects affected / exposed
|
8 / 2218 (0.36%) |
16 / 2241 (0.71%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
2 / 2241 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus inadequate control
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrolyte imbalance
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fluid overload
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypocalcaemia
|
|
|
subjects affected / exposed
|
3 / 2218 (0.14%) |
5 / 2241 (0.22%) |
occurrences causally related to treatment / all
|
2 / 3 |
5 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
6 / 2241 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
1 / 2218 (0.05%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypophosphataemia
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
subjects affected / exposed
|
2 / 2218 (0.09%) |
0 / 2241 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitamin D deficiency
|
|
|
subjects affected / exposed
|
0 / 2218 (0.00%) |
1 / 2241 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |