Serious adverse events
|
OCA 10 Milligrams (mg) |
OCA 25 mg |
Placebo |
Total subjects affected by serious adverse events
|
|
|
|
subjects affected / exposed
|
273 / 825 (33.09%) |
276 / 827 (33.37%) |
248 / 825 (30.06%) |
number of deaths (all causes)
|
14 |
19 |
14 |
number of deaths resulting from adverse events
|
14 |
19 |
14 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
Adenocarcinoma of salivary gland
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal squamous cell carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign hepatic neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign neoplasm of spinal cord
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign salivary gland neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma recurrent
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bone cancer
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast cancer
|
|
|
|
subjects affected / exposed
|
4 / 825 (0.48%) |
2 / 827 (0.24%) |
4 / 825 (0.48%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast cancer metastatic
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast cancer recurrent
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholangiocarcinoma
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic lymphocytic leukaemia
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic myeloid leukaemia
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clear cell renal cell carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colon adenoma
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diffuse large B-cell lymphoma
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
3 / 825 (0.36%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial adenocarcinoma
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial cancer
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial cancer metastatic
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal stromal tumour
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Glioblastoma
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemangiopericytoma
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic cancer
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatocellular carcinoma
|
|
|
|
subjects affected / exposed
|
8 / 825 (0.97%) |
6 / 827 (0.73%) |
3 / 825 (0.36%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 9 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intraductal papillary mucinous neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intraductal papilloma of breast
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intraductal proliferative breast lesion
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Invasive breast carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Invasive ductal breast carcinoma
|
|
|
|
subjects affected / exposed
|
5 / 825 (0.61%) |
0 / 827 (0.00%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine benign neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lip and/or oral cavity cancer
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
2 / 827 (0.24%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Lung neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Lung neoplasm malignant
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lymphoma
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malignant pleural effusion
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to bone
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to central nervous system
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to skin
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neoplasm malignant
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neuroendocrine tumour
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oral papilloma
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Papillary thyroid cancer
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
2 / 827 (0.24%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Parathyroid tumour benign
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Phaeochromocytoma
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
2 / 827 (0.24%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pleomorphic adenoma
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
|
subjects affected / exposed
|
5 / 825 (0.61%) |
4 / 827 (0.48%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer metastatic
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer recurrent
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
2 / 827 (0.24%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer stage II
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal cancer
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal cell carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Small cell lung cancer
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Squamous cell carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of lung
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
2 / 827 (0.24%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thyroid cancer
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tongue neoplasm malignant stage unspecified
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transitional cell carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine leiomyosarcoma
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
PNEUMONIA METASTASIS OF OESOPHAGEAL CANCER
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
Aortic dissection
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic stenosis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arterial haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arterial occlusive disease
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Hypertension
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
2 / 827 (0.24%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
0 / 827 (0.00%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypotension
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
3 / 827 (0.36%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Shock
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Shock haemorrhagic
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
2 / 827 (0.24%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Varicose vein
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
|
Liver transplant
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Physiotherapy
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rotator cuff repair
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pregnancy, puerperium and perinatal conditions
|
|
|
|
Abortion spontaneous
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
Hiatus hernia
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adverse drug reaction
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Asthenia
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
2 / 827 (0.24%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast complication associated with device
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Calcinosis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chest discomfort
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chest pain
|
|
|
|
subjects affected / exposed
|
5 / 825 (0.61%) |
8 / 827 (0.97%) |
6 / 825 (0.73%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Death
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
2 / 827 (0.24%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device deployment issue
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device dislocation
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Disease progression
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dysplasia
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mass
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
|
subjects affected / exposed
|
3 / 825 (0.36%) |
7 / 827 (0.85%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
3 / 827 (0.36%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Systemic inflammatory response syndrome
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
2 / 827 (0.24%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular stent occlusion
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
Anaphylactic reaction
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Drug hypersensitivity
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypersensitivity
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
|
subjects affected / exposed
|
4 / 825 (0.48%) |
4 / 827 (0.48%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
Benign prostatic hyperplasia
|
|
|
|
subjects affected / exposed
|
3 / 825 (0.36%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast haematoma
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial hyperplasia
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial thickening
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Menorrhagia
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metrorrhagia
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic congestion
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic pain
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic prolapse
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectocele
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine polyp
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine prolapse
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterovaginal prolapse
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
Acute respiratory distress syndrome
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute respiratory failure
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
2 / 827 (0.24%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Asthma
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
5 / 827 (0.60%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Asthma-chronic obstructive pulmonary disease overlap syndrome
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atelectasis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchopneumopathy
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
|
subjects affected / exposed
|
5 / 825 (0.61%) |
3 / 827 (0.36%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cough
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
|
subjects affected / exposed
|
3 / 825 (0.36%) |
5 / 827 (0.60%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Dyspnoea exertional
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemothorax
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Idiopathic pulmonary fibrosis
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nasopharyngeal polyp
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Organising pneumonia
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumothorax spontaneous
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary alveolar haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
|
subjects affected / exposed
|
3 / 825 (0.36%) |
1 / 827 (0.12%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary fibrosis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Pulmonary hilum mass
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary mass
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory distress
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
Adjustment disorder with depressed mood
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bipolar I disorder
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bipolar disorder
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
Confusional state
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
2 / 827 (0.24%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Depression
|
|
|
|
subjects affected / exposed
|
3 / 825 (0.36%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Major depression
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mental disorder
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Panic disorder
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Psychogenic seizure
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Psychogenic tremor
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rapid eye movements sleep abnormal
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Suicidal ideation
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
2 / 827 (0.24%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Suicide attempt
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ANXIETY-DEPRESSIVE DISORDER
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
Acute hepatic failure
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Autoimmune hepatitis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct obstruction
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct stone
|
|
|
|
subjects affected / exposed
|
3 / 825 (0.36%) |
3 / 827 (0.36%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Biliary colic
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
2 / 827 (0.24%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Biliary tract disorder
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Biloma
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
2 / 827 (0.24%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholangitis acute
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
4 / 827 (0.48%) |
4 / 825 (0.48%) |
occurrences causally related to treatment / all
|
0 / 2 |
2 / 4 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
9 / 827 (1.09%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 9 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis chronic
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
2 / 827 (0.24%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
|
subjects affected / exposed
|
4 / 825 (0.48%) |
8 / 827 (0.97%) |
4 / 825 (0.48%) |
occurrences causally related to treatment / all
|
3 / 4 |
2 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholestasis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholestatic liver injury
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic hepatic failure
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Drug-induced liver injury
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
3 / 827 (0.36%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gallbladder perforation
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gallbladder polyp
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic cirrhosis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
2 / 827 (0.24%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic failure
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic haematoma
|
|
|
|
subjects affected / exposed
|
3 / 825 (0.36%) |
2 / 827 (0.24%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic lesion
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatorenal syndrome
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperbilirubinaemia
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
2 / 827 (0.24%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperplastic cholecystopathy
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
Arthroscopy
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood bilirubin increased
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood creatine phosphokinase increased
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronavirus test positive
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fibrin D dimer increased
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gamma-glutamyltransferase increased
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemoglobin decreased
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Human rhinovirus test positive
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Liver function test abnormal
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Red blood cell sedimentation rate increased
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transaminases increased
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Troponin increased
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Weight increased
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
Accidental overdose
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Alcohol poisoning
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anaesthetic complication pulmonary
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
3 / 827 (0.36%) |
3 / 825 (0.36%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervical vertebral fracture
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chest injury
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Concussion
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fall
|
|
|
|
subjects affected / exposed
|
3 / 825 (0.36%) |
3 / 827 (0.36%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Head injury
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
2 / 827 (0.24%) |
4 / 825 (0.48%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated incisional hernia
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intentional overdose
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Joint injury
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Laceration
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Near drowning
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Overdose
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Patella fracture
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pharyngeal injury
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural complication
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
3 / 825 (0.36%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural discomfort
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
|
subjects affected / exposed
|
5 / 825 (0.61%) |
3 / 827 (0.36%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
4 / 827 (0.48%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural inflammation
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Procedural intestinal perforation
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Procedural pain
|
|
|
|
subjects affected / exposed
|
4 / 825 (0.48%) |
6 / 827 (0.73%) |
4 / 825 (0.48%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
2 / 827 (0.24%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Seroma
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Shunt malfunction
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin graft failure
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal column injury
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal cord injury cervical
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
2 / 827 (0.24%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic haematoma
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary retention postoperative
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound secretion
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
INTRACRANIAL HEMORRHAGE
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
|
Arnold-Chiari malformation
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriovenous malformation
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Congenital cerebrovascular anomaly
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rathke's cleft cyst
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
Acute coronary syndrome
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute myocardial infarction
|
|
|
|
subjects affected / exposed
|
4 / 825 (0.48%) |
7 / 827 (0.85%) |
4 / 825 (0.48%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 9 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
|
subjects affected / exposed
|
4 / 825 (0.48%) |
6 / 827 (0.73%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
2 / 827 (0.24%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
|
subjects affected / exposed
|
8 / 825 (0.97%) |
5 / 827 (0.60%) |
4 / 825 (0.48%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 10 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
2 / 827 (0.24%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Cardiac failure congestive
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
2 / 827 (0.24%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardio-respiratory distress
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Congestive cardiomyopathy
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Cor pulmonale
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
|
subjects affected / exposed
|
5 / 825 (0.61%) |
4 / 827 (0.48%) |
7 / 825 (0.85%) |
occurrences causally related to treatment / all
|
2 / 5 |
0 / 4 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery occlusion
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive heart disease
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
3 / 827 (0.36%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Myocardial ischaemia
|
|
|
|
subjects affected / exposed
|
4 / 825 (0.48%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Palpitations
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
2 / 827 (0.24%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pericarditis constrictive
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinus tachycardia
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular tachycardia
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
|
Ataxia
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Autonomic nervous system imbalance
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain mass
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain stem haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cauda equina syndrome
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral infarction
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrospinal fluid leakage
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
3 / 827 (0.36%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervical radiculopathy
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cognitive disorder
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dementia
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Depressed level of consciousness
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dizziness
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
0 / 827 (0.00%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dysarthria
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Essential tremor
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Headache
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic encephalopathy
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
2 / 827 (0.24%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoaesthesia
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
2 / 827 (0.24%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intracranial aneurysm
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intracranial pressure increased
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
3 / 827 (0.36%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lacunar stroke
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lumbosacral radiculopathy
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Migraine
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
4 / 827 (0.48%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Motor neurone disease
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nerve compression
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorder
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Optic neuritis
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Parkinson's disease
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Parkinsonism
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Polyneuropathy
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post herpetic neuralgia
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Presyncope
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
3 / 827 (0.36%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sciatica
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Seizure
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
2 / 827 (0.24%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sensory disturbance
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal epidural haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Syncope
|
|
|
|
subjects affected / exposed
|
7 / 825 (0.85%) |
3 / 827 (0.36%) |
5 / 825 (0.61%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thalamic infarction
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transient global amnesia
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
3 / 827 (0.36%) |
3 / 825 (0.36%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Trigeminal neuralgia
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
VIIth nerve paralysis
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
VIth nerve paralysis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vertebrobasilar insufficiency
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
Anaemia
|
|
|
|
subjects affected / exposed
|
4 / 825 (0.48%) |
2 / 827 (0.24%) |
3 / 825 (0.36%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Febrile neutropenia
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Polycythaemia
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Splenic lesion
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
|
Labyrinthine fistula
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
2 / 827 (0.24%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
Macular fibrosis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Optic ischaemic neuropathy
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vision blurred
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
Abdominal discomfort
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
|
subjects affected / exposed
|
7 / 825 (0.85%) |
4 / 827 (0.48%) |
7 / 825 (0.85%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 9 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
0 / 827 (0.00%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal wall disorder
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal wall haematoma
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Apical granuloma
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Appendix disorder
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ascites
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
2 / 827 (0.24%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colitis ulcerative
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colonic fistula
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Constipation
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
3 / 825 (0.36%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
4 / 827 (0.48%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum intestinal
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dyschezia
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Enteritis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Enterocolitis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric polyps
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
2 / 827 (0.24%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
3 / 825 (0.36%) |
3 / 827 (0.36%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematochezia
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Impaired gastric emptying
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
3 / 827 (0.36%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 9 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated umbilical hernia
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal ischaemia
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intra-abdominal haematoma
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Melaena
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nausea
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal obstruction
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal varices haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
2 / 827 (0.24%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
|
subjects affected / exposed
|
4 / 825 (0.48%) |
6 / 827 (0.73%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
2 / 4 |
2 / 7 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
|
subjects affected / exposed
|
5 / 825 (0.61%) |
1 / 827 (0.12%) |
3 / 825 (0.36%) |
occurrences causally related to treatment / all
|
2 / 6 |
1 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis haemorrhagic
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peritoneal haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Portal hypertensive gastropathy
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retroperitoneal haematoma
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
5 / 827 (0.60%) |
5 / 825 (0.61%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Stomatitis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Varices oesophageal
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vomiting
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
2 / 827 (0.24%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
Angioedema
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
2 / 827 (0.24%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Decubitus ulcer
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dermatomyositis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic foot
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hidradenitis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lichen sclerosus
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pruritus
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
5 / 827 (0.60%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
5 / 5 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
Acute kidney injury
|
|
|
|
subjects affected / exposed
|
6 / 825 (0.73%) |
13 / 827 (1.57%) |
4 / 825 (0.48%) |
occurrences causally related to treatment / all
|
0 / 6 |
3 / 14 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
Bladder prolapse
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Calculus ureteric
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Calculus urinary
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis haemorrhagic
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
2 / 827 (0.24%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic nephropathy
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower urinary tract symptoms
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
|
subjects affected / exposed
|
5 / 825 (0.61%) |
5 / 827 (0.60%) |
5 / 825 (0.61%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pelvi-ureteric obstruction
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal aneurysm
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal colic
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal failure
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ureteric obstruction
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
|
Adrenal haematoma
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Goitre
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pituitary-dependent Cushing's syndrome
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thyroid mass
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thyroiditis subacute
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
Arthralgia
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis
|
|
|
|
subjects affected / exposed
|
3 / 825 (0.36%) |
2 / 827 (0.24%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Back pain
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bone disorder
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervical spinal stenosis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Costochondritis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fracture nonunion
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gouty arthritis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Inclusion body myositis
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc degeneration
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
0 / 827 (0.00%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
|
subjects affected / exposed
|
3 / 825 (0.36%) |
3 / 827 (0.36%) |
6 / 825 (0.73%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
3 / 827 (0.36%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myalgia
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myopathy
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myositis
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
|
subjects affected / exposed
|
6 / 825 (0.73%) |
8 / 827 (0.97%) |
6 / 825 (0.73%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 9 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteonecrosis of jaw
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Polymyalgia rheumatica
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Psoriatic arthropathy
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
2 / 827 (0.24%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal column stenosis
|
|
|
|
subjects affected / exposed
|
3 / 825 (0.36%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tendon calcification
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vertebral foraminal stenosis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
Abscess limb
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal infection
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis perforated
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchiolitis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
subjects affected / exposed
|
3 / 825 (0.36%) |
5 / 827 (0.60%) |
6 / 825 (0.73%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis infective
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic sinusitis
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
3 / 827 (0.36%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile infection
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coccidioidomycosis
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Corona virus infection
|
|
|
|
subjects affected / exposed
|
6 / 825 (0.73%) |
7 / 827 (0.85%) |
6 / 825 (0.73%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
3 / 827 (0.36%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cytomegalovirus mononucleosis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device related infection
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea infectious
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
|
subjects affected / exposed
|
3 / 825 (0.36%) |
2 / 827 (0.24%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Encephalitis viral
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endocarditis bacterial
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gangrene
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
4 / 827 (0.48%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Graft infection
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Groin abscess
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Helicobacter infection
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis E
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Histoplasmosis
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infection
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Influenza
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Joint abscess
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Kidney infection
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Liver abscess
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Localised infection
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mastoiditis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Medical device site joint infection
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Parotid abscess
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic abscess
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Perirectal abscess
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pharyngeal abscess
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
|
subjects affected / exposed
|
5 / 825 (0.61%) |
9 / 827 (1.09%) |
7 / 825 (0.85%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia viral
|
|
|
|
subjects affected / exposed
|
9 / 825 (1.09%) |
10 / 827 (1.21%) |
4 / 825 (0.48%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 10 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural cellulitis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural infection
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural sepsis
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pseudomonas infection
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary sepsis
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
|
subjects affected / exposed
|
5 / 825 (0.61%) |
4 / 827 (0.48%) |
3 / 825 (0.36%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rotavirus infection
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Salmonellosis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sepsis
|
|
|
|
subjects affected / exposed
|
7 / 825 (0.85%) |
6 / 827 (0.73%) |
7 / 825 (0.85%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sepsis syndrome
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Septic encephalopathy
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Septic shock
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
3 / 827 (0.36%) |
3 / 825 (0.36%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinusitis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal bacteraemia
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal infection
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
2 / 827 (0.24%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Streptococcal bacteraemia
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Streptococcal sepsis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subcutaneous abscess
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tonsillitis
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tooth infection
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tracheobronchitis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
|
subjects affected / exposed
|
3 / 825 (0.36%) |
5 / 827 (0.60%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
3 / 827 (0.36%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Varicella
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vestibular neuronitis
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Viral pericarditis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vulval abscess
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound infection
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
Dehydration
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
4 / 827 (0.48%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetes mellitus inadequate control
|
|
|
|
subjects affected / exposed
|
3 / 825 (0.36%) |
3 / 827 (0.36%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
|
subjects affected / exposed
|
3 / 825 (0.36%) |
2 / 827 (0.24%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Electrolyte imbalance
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Failure to thrive
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fluid overload
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gout
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypercreatininaemia
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
2 / 827 (0.24%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
2 / 825 (0.24%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
|
subjects affected / exposed
|
2 / 825 (0.24%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lactic acidosis
|
|
|
|
subjects affected / exposed
|
0 / 825 (0.00%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Obesity
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
0 / 827 (0.00%) |
1 / 825 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
|
subjects affected / exposed
|
1 / 825 (0.12%) |
1 / 827 (0.12%) |
0 / 825 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |