Serious adverse events
|
Etanercept |
Tocilizumab |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
422 / 1542 (27.37%) |
479 / 1538 (31.14%) |
number of deaths (all causes)
|
69 |
67 |
number of deaths resulting from adverse events
|
10 |
14 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
ADENOCARCINOMA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ADENOCARCINOMA OF COLON
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ANAL SQUAMOUS CELL CARCINOMA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BASAL CELL CARCINOMA
|
|
|
subjects affected / exposed
|
3 / 1542 (0.19%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BENIGN ANORECTAL NEOPLASM
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BENIGN NEOPLASM OF CERVIX UTERI
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BLADDER CANCER
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
BLADDER TRANSITIONAL CELL CARCINOMA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BRAIN NEOPLASM
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
BREAST CANCER
|
|
|
subjects affected / exposed
|
3 / 1542 (0.19%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
1 / 3 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
CARCINOID TUMOUR OF THE GASTROINTESTINAL TRACT
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CARCINOID TUMOUR PULMONARY
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CARDIAC MYXOMA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CENTRAL NERVOUS SYSTEM LYMPHOMA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CEREBRAL HAEMANGIOMA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHOLANGIOCARCINOMA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
COLON ADENOMA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COLON CANCER
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COLON CANCER METASTATIC
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
COLORECTAL CANCER
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DIFFUSE LARGE B−CELL LYMPHOMA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ENDOMETRIAL ADENOCARCINOMA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GLIOBLASTOMA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMANGIOMA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INTESTINAL ADENOCARCINOMA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INTRADUCTAL PROLIFERATIVE BREAST LESION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LARYNGEAL CANCER
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LUNG ADENOCARCINOMA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
LUNG ADENOCARCINOMA STAGE IV
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
LUNG CANCER METASTATIC
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
LUNG NEOPLASM
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
LUNG NEOPLASM MALIGNANT
|
|
|
subjects affected / exposed
|
4 / 1542 (0.26%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
1 / 3 |
MALIGNANT MELANOMA STAGE II
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MARJOLIN’S ULCER
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
METASTASES TO BONE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
METASTATIC GASTRIC CANCER
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
METASTATIC NEOPLASM
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
NEOPLASM MALIGNANT
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
NON−HODGKIN’S LYMPHOMA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OVARIAN ADENOMA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OVARIAN CANCER
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
PANCREATIC CARCINOMA METASTATIC
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
PANCREATIC NEOPLASM
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
PAPILLARY THYROID CANCER
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PARAPROTEINAEMIA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PARATHYROID TUMOUR BENIGN
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PHARYNGEAL NEOPLASM BENIGN
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PITUITARY TUMOUR BENIGN
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PLASMA CELL MYELOMA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PROSTATE CANCER
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RENAL CANCER
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RENAL CELL CARCINOMA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SMALL CELL LUNG CANCER
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SQUAMOUS CELL CARCINOMA OF LUNG
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SQUAMOUS CELL CARCINOMA OF THE TONGUE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SQUAMOUS ENDOMETRIAL CARCINOMA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
THYROID ADENOMA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TUMOUR INVASION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
UTERINE CANCER
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Vascular disorders
|
|
|
AORTIC ANEURYSM
|
|
|
subjects affected / exposed
|
4 / 1542 (0.26%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
AORTIC ANEURYSM RUPTURE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
AORTIC CALCIFICATION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
AORTIC DISSECTION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
AORTIC STENOSIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DEEP VEIN THROMBOSIS
|
|
|
subjects affected / exposed
|
8 / 1542 (0.52%) |
6 / 1538 (0.39%) |
occurrences causally related to treatment / all
|
0 / 8 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
EMBOLISM ARTERIAL
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FEMORAL ARTERY EMBOLISM
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMATOMA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPERTENSION
|
|
|
subjects affected / exposed
|
6 / 1542 (0.39%) |
4 / 1538 (0.26%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPERTENSIVE CRISIS
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPERTENSIVE EMERGENCY
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPOTENSION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INFARCTION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ORTHOSTATIC HYPOTENSION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PERIPHERAL ISCHAEMIA
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PERIPHERAL VENOUS DISEASE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
SUBCLAVIAN ARTERY OCCLUSION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RHEUMATOID VASCULITIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
THROMBOSIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VARICOSE VEIN
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VENOUS THROMBOSIS LIMB
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
ABDOMINAL HERNIA REPAIR
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ANAL FISTULA EXCISION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ANGIOPLASTY
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
APPENDICECTOMY
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CARDIAC PACEMAKER REPLACEMENT
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COLOSTOMY CLOSURE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HIP ARTHROPLASTY
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
IMPLANTABLE DEFIBRILLATOR INSERTION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
KNEE ARTHROPLASTY
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LARGE INTESTINE ANASTOMOSIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MITRAL VALVE REPLACEMENT
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SEQUESTRECTOMY
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
UMBILICAL HERNIA REPAIR
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
CHEST PAIN
|
|
|
subjects affected / exposed
|
10 / 1542 (0.65%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COMPLICATION ASSOCIATED WITH DEVICE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DEATH
|
|
|
subjects affected / exposed
|
4 / 1542 (0.26%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 3 |
GENERAL PHYSICAL HEALTH DETERIORATION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
IMPAIRED HEALING
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LOCAL SWELLING
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MULTIPLE ORGAN DYSFUNCTION SYNDROME
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
NON−CARDIAC CHEST PAIN
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
5 / 1538 (0.33%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OEDEMA PERIPHERAL
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PYREXIA
|
|
|
subjects affected / exposed
|
3 / 1542 (0.19%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
1 / 3 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PAIN
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
SUDDEN DEATH
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
SWELLING
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Immune system disorders
|
|
|
DRUG HYPERSENSITIVITY
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPERSENSITIVITY
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OVERLAP SYNDROME
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SARCOIDOSIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
ACQUIRED PHIMOSIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BREAST FIBROSIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CERVICAL DYSPLASIA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CERVICAL POLYP
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CYSTOCELE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GENITAL PROLAPSE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
METRORRHAGIA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OVARIAN CYST
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OVARIAN CYST TORSION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RECTOCELE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SPERMATOCELE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
UTERINE POLYP
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
UTERINE PROLAPSE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VAGINAL HAEMATOMA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
ACUTE PULMONARY OEDEMA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ACUTE RESPIRATORY DISTRESS SYNDROME
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
ACUTE RESPIRATORY FAILURE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ALVEOLITIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ASTHMA
|
|
|
subjects affected / exposed
|
5 / 1542 (0.32%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ASTHMATIC CRISIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ATELECTASIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BRONCHIAL HYPERREACTIVITY
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BRONCHIAL OBSTRUCTION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BRONCHITIS CHRONIC
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BRONCHOSPASM
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BRONCHOSTENOSIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
|
|
subjects affected / exposed
|
7 / 1542 (0.45%) |
10 / 1538 (0.65%) |
occurrences causally related to treatment / all
|
2 / 7 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
CHRONIC RESPIRATORY FAILURE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DYSPNOEA
|
|
|
subjects affected / exposed
|
4 / 1542 (0.26%) |
5 / 1538 (0.33%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
EMPHYSEMA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
EPISTAXIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYDROTHORAX
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INTERSTITIAL LUNG DISEASE
|
|
|
subjects affected / exposed
|
3 / 1542 (0.19%) |
5 / 1538 (0.33%) |
occurrences causally related to treatment / all
|
1 / 3 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPOXIA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LUNG DISORDER
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LUNG INFILTRATION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PLEURAL EFFUSION
|
|
|
subjects affected / exposed
|
5 / 1542 (0.32%) |
6 / 1538 (0.39%) |
occurrences causally related to treatment / all
|
0 / 6 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PNEUMONIA ASPIRATION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PNEUMOTHORAX
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PNEUMONITIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PULMONARY EMBOLISM
|
|
|
subjects affected / exposed
|
11 / 1542 (0.71%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
2 / 11 |
0 / 1 |
deaths causally related to treatment / all
|
1 / 2 |
0 / 0 |
PULMONARY FIBROSIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
PULMONARY HYPERTENSION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PULMONARY GRANULOMA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PULMONARY MASS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PULMONARY OEDEMA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PULMONARY SARCOIDOSIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RESPIRATORY DISTRESS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PULMONARY THROMBOSIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
RESPIRATORY FAILURE
|
|
|
subjects affected / exposed
|
6 / 1542 (0.39%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
2 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
1 / 3 |
0 / 0 |
Psychiatric disorders
|
|
|
BURNOUT SYNDROME
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CONFUSIONAL STATE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DELIRIUM
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DELIRIUM TREMENS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DEPRESSION
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MAJOR DEPRESSION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MENTAL DISORDER
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MENTAL STATUS CHANGES
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PSYCHOTIC DISORDER
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SCHIZOAFFECTIVE DISORDER BIPOLAR TYPE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SUICIDAL IDEATION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SUICIDE ATTEMPT
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MANIA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product issues
|
|
|
DEVICE BREAKAGE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DEVICE DISLOCATION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DEVICE FAILURE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DEVICE LOOSENING
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
BILE DUCT OBSTRUCTION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHOLECYSTITIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHOLANGITIS ACUTE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHOLECYSTITIS ACUTE
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHOLECYSTITIS CHRONIC
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHOLELITHIASIS
|
|
|
subjects affected / exposed
|
6 / 1542 (0.39%) |
14 / 1538 (0.91%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATIC VEIN THROMBOSIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATITIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATITIS ACUTE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
POST CHOLECYSTECTOMY SYNDROME
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
EOSINOPHIL COUNT INCREASED
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMATOCRIT ABNORMAL
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMOGLOBIN ABNORMAL
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LIVER FUNCTION TEST INCREASED
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
STAPHYLOCOCCUS TEST POSITIVE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SYNOVIAL FLUID WHITE BLOOD CELLS POSITIVE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TRANSAMINASES INCREASED
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TROPONIN INCREASED
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
ACCIDENT AT WORK
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
ANAEMIA POSTOPERATIVE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ANKLE FRACTURE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ARTHROPOD STING
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
COMMINUTED FRACTURE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CONTUSION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DISLOCATION OF VERTEBRA
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
FALL
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FEMORAL NECK FRACTURE
|
|
|
subjects affected / exposed
|
3 / 1542 (0.19%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FEMUR FRACTURE
|
|
|
subjects affected / exposed
|
6 / 1542 (0.39%) |
5 / 1538 (0.33%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FOOT FRACTURE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FRACTURE DISPLACEMENT
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GUN SHOT WOUND
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
HAND FRACTURE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HIP FRACTURE
|
|
|
subjects affected / exposed
|
12 / 1542 (0.78%) |
4 / 1538 (0.26%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HUMERUS FRACTURE
|
|
|
subjects affected / exposed
|
4 / 1542 (0.26%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INFUSION RELATED REACTION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
JOINT DISLOCATION
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
JOINT INJURY
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LIGAMENT INJURY
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LOWER LIMB FRACTURE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OVERDOSE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PATELLA FRACTURE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PNEUMOTHORAX TRAUMATIC
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
POST PROCEDURAL FISTULA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
POST PROCEDURAL HAEMATOMA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RADIUS FRACTURE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RESPIRATORY FUME INHALATION DISORDER
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RIB FRACTURE
|
|
|
subjects affected / exposed
|
4 / 1542 (0.26%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SPINAL COMPRESSION FRACTURE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SPINAL FRACTURE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
STOMAL HERNIA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
STRESS FRACTURE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SUBCUTANEOUS HAEMATOMA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SUBDURAL HAEMATOMA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SYNOVIAL RUPTURE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TENDON RUPTURE
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
THORACIC VERTEBRAL FRACTURE
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ULNA FRACTURE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
UPPER LIMB FRACTURE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
WOUND
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
WOUND DEHISCENCE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
WRIST FRACTURE
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
ATRIAL SEPTAL DEFECT
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYDROCELE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
ACUTE CORONARY SYNDROME
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ADAMS−STOKES SYNDROME
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ACUTE MYOCARDIAL INFARCTION
|
|
|
subjects affected / exposed
|
9 / 1542 (0.58%) |
7 / 1538 (0.46%) |
occurrences causally related to treatment / all
|
1 / 9 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
ANGINA PECTORIS
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
8 / 1538 (0.52%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ANGINA UNSTABLE
|
|
|
subjects affected / exposed
|
7 / 1542 (0.45%) |
4 / 1538 (0.26%) |
occurrences causally related to treatment / all
|
0 / 10 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ATRIAL FLUTTER
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ATRIAL FIBRILLATION
|
|
|
subjects affected / exposed
|
18 / 1542 (1.17%) |
14 / 1538 (0.91%) |
occurrences causally related to treatment / all
|
3 / 23 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ATRIOVENTRICULAR BLOCK SECOND DEGREE
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BRADYARRHYTHMIA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BRADYCARDIA
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BUNDLE BRANCH BLOCK LEFT
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CARDIAC ARREST
|
|
|
subjects affected / exposed
|
4 / 1542 (0.26%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 1 |
CARDIAC FAILURE
|
|
|
subjects affected / exposed
|
3 / 1542 (0.19%) |
11 / 1538 (0.72%) |
occurrences causally related to treatment / all
|
0 / 3 |
5 / 16 |
deaths causally related to treatment / all
|
0 / 1 |
1 / 3 |
CARDIAC FAILURE CHRONIC
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
CARDIAC FAILURE CONGESTIVE
|
|
|
subjects affected / exposed
|
8 / 1542 (0.52%) |
7 / 1538 (0.46%) |
occurrences causally related to treatment / all
|
2 / 11 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
CARDIAC FIBRILLATION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CARDIAC TAMPONADE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CARDIOGENIC SHOCK
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CARDIOMYOPATHY
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CARDIOPULMONARY FAILURE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
4 / 1538 (0.26%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 4 |
CORONARY ARTERY DISEASE
|
|
|
subjects affected / exposed
|
3 / 1542 (0.19%) |
9 / 1538 (0.59%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CORONARY ARTERY OCCLUSION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
CORONARY ARTERY STENOSIS
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPERTENSIVE HEART DISEASE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ISCHAEMIC CARDIOMYOPATHY
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LEFT VENTRICULAR FAILURE
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
MITRAL VALVE INCOMPETENCE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MITRAL VALVE STENOSIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MYOCARDIAL INFARCTION
|
|
|
subjects affected / exposed
|
15 / 1542 (0.97%) |
10 / 1538 (0.65%) |
occurrences causally related to treatment / all
|
2 / 15 |
0 / 10 |
deaths causally related to treatment / all
|
1 / 5 |
0 / 1 |
MYOCARDIAL ISCHAEMIA
|
|
|
subjects affected / exposed
|
3 / 1542 (0.19%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
PALPITATIONS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
POSTINFARCTION ANGINA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SILENT MYOCARDIAL INFARCTION
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SINOATRIAL BLOCK
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SINUS BRADYCARDIA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SINUS NODE DYSFUNCTION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SUPRAVENTRICULAR TACHYCARDIA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TACHYCARDIA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VENTRICULAR DYSFUNCTION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VENTRICULAR FIBRILLATION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VENTRICULAR TACHYCARDIA
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CARDIO−RESPIRATORY ARREST
|
|
|
subjects affected / exposed
|
3 / 1542 (0.19%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
1 / 3 |
0 / 1 |
Nervous system disorders
|
|
|
AMYOTROPHIC LATERAL SCLEROSIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BALANCE DISORDER
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BRAIN STEM INFARCTION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CAROTID ARTERY DISEASE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CAROTID ARTERY STENOSIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CEREBRAL HAEMATOMA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CEREBRAL INFARCTION
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CEREBRAL ISCHAEMIA
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CEREBROVASCULAR ACCIDENT
|
|
|
subjects affected / exposed
|
8 / 1542 (0.52%) |
14 / 1538 (0.91%) |
occurrences causally related to treatment / all
|
0 / 8 |
2 / 15 |
deaths causally related to treatment / all
|
0 / 3 |
1 / 3 |
CEREBROVASCULAR DISORDER
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CERVICAL CORD COMPRESSION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CERVICAL RADICULOPATHY
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COMA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
DEMENTIA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DEMENTIA ALZHEIMER’S TYPE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
DIABETIC COMA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DYSARTHRIA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DYSKINESIA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
EMBOLIC STROKE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ENCEPHALOPATHY
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
EPILEPSY
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FACIAL PARALYSIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GENERALISED TONIC−CLONIC SEIZURE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMORRHAGIC STROKE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
HEMIPARESIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HEPATIC ENCEPHALOPATHY
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPERTENSIVE ENCEPHALOPATHY
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INTRACRANIAL ANEURYSM
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ISCHAEMIC STROKE
|
|
|
subjects affected / exposed
|
5 / 1542 (0.32%) |
5 / 1538 (0.33%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
LOSS OF CONSCIOUSNESS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
METABOLIC ENCEPHALOPATHY
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LUMBAR RADICULOPATHY
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MIGRAINE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MYASTHENIA GRAVIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PARKINSON’S DISEASE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PARAESTHESIA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PRESYNCOPE
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
REVERSIBLE ISCHAEMIC NEUROLOGICAL DEFICIT
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RUPTURED CEREBRAL ANEURYSM
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SCIATICA
|
|
|
subjects affected / exposed
|
3 / 1542 (0.19%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SPINAL CORD COMPRESSION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
SEIZURE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SUBARACHNOID HAEMORRHAGE
|
|
|
subjects affected / exposed
|
3 / 1542 (0.19%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
SYNCOPE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TRANSIENT GLOBAL AMNESIA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VASCULAR DEMENTIA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
TRANSIENT ISCHAEMIC ATTACK
|
|
|
subjects affected / exposed
|
3 / 1542 (0.19%) |
9 / 1538 (0.59%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
ANAEMIA
|
|
|
subjects affected / exposed
|
9 / 1542 (0.58%) |
5 / 1538 (0.33%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
AUTOIMMUNE HAEMOLYTIC ANAEMIA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COAGULOPATHY
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GRANULOCYTOPENIA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LEUKOCYTOSIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MICROCYTIC ANAEMIA
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PANCYTOPENIA
|
|
|
subjects affected / exposed
|
4 / 1542 (0.26%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
THROMBOCYTOPENIA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LEUKOPENIA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
DEAFNESS UNILATERAL
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VERTIGO
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
CATARACT
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CORNEAL PERFORATION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
KERATITIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RETINAL ARTERY OCCLUSION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RETINAL DETACHMENT
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ULCERATIVE KERATITIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SCLERITIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
ABDOMINAL ADHESIONS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ABDOMINAL HERNIA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ABDOMINAL PAIN
|
|
|
subjects affected / exposed
|
4 / 1542 (0.26%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
ABDOMINAL PAIN UPPER
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ACID PEPTIC DISEASE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ACUTE ABDOMEN
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
ASCITES
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COLITIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COLITIS ISCHAEMIC
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COLITIS ULCERATIVE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CONSTIPATION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CROHN’S DISEASE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DIAPHRAGMATIC HERNIA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DIARRHOEA
|
|
|
subjects affected / exposed
|
4 / 1542 (0.26%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DIVERTICULAR PERFORATION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
6 / 1538 (0.39%) |
occurrences causally related to treatment / all
|
0 / 1 |
6 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DIVERTICULUM
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DIVERTICULUM INTESTINAL
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DIVERTICULUM INTESTINAL HAEMORRHAGIC
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DUODENAL ULCER
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ENTERITIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ENTEROCOLITIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FEMORAL HERNIA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTRIC ULCER HAEMORRHAGE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTRIC ULCER
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTRIC ULCER PERFORATION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTRITIS
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
4 / 1538 (0.26%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROINTESTINAL HAEMORRHAGE
|
|
|
subjects affected / exposed
|
4 / 1542 (0.26%) |
4 / 1538 (0.26%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
GASTRITIS HAEMORRHAGIC
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROINTESTINAL INFLAMMATION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROINTESTINAL ULCER HAEMORRHAGE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROOESOPHAGEAL REFLUX DISEASE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMATEMESIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
HAEMATOCHEZIA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INCARCERATED HIATUS HERNIA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMORRHOIDS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INCARCERATED UMBILICAL HERNIA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INGUINAL HERNIA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INTESTINAL OBSTRUCTION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LARGE INTESTINAL STENOSIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LARGE INTESTINE PERFORATION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
4 / 1538 (0.26%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LARGE INTESTINE POLYP
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LOWER GASTROINTESTINAL HAEMORRHAGE
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MALLORY−WEISS SYNDROME
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MELAENA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
NAUSEA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OESOPHAGITIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PALATAL DISORDER
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PANCREATITIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
4 / 1538 (0.26%) |
occurrences causally related to treatment / all
|
0 / 1 |
3 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PANCREATITIS ACUTE
|
|
|
subjects affected / exposed
|
3 / 1542 (0.19%) |
5 / 1538 (0.33%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
PEPTIC ULCER
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PEPTIC ULCER HAEMORRHAGE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
RETROPERITONEAL FIBROSIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
UPPER GASTROINTESTINAL HAEMORRHAGE
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
VOMITING
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
ANGIOEDEMA
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BLISTER
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DECUBITUS ULCER
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DERMAL CYST
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DERMATITIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DIABETIC FOOT
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPERSENSITIVITY VASCULITIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
PEMPHIGOID
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RASH
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RASH ERYTHEMATOUS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SKIN DISORDER
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SKIN NECROSIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SKIN ULCER
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
4 / 1538 (0.26%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
URTICARIA
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VASCULITIC ULCER
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
ACUTE KIDNEY INJURY
|
|
|
subjects affected / exposed
|
5 / 1542 (0.32%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CALCULUS URINARY
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CALCULUS BLADDER
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHRONIC KIDNEY DISEASE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
CYSTITIS HAEMORRHAGIC
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
END STAGE RENAL DISEASE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
GLOMERULONEPHRITIS CHRONIC
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYDRONEPHROSIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
NEPHROLITHIASIS
|
|
|
subjects affected / exposed
|
3 / 1542 (0.19%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OBSTRUCTIVE NEPHROPATHY
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PELVI−URETERIC OBSTRUCTION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RENAL COLIC
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RENAL FAILURE
|
|
|
subjects affected / exposed
|
3 / 1542 (0.19%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TUBULOINTERSTITIAL NEPHRITIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
URETERIC OBSTRUCTION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
URETEROLITHIASIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
URETHRAL STENOSIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
URINARY RETENTION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
GOITRE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPOTHYROIDISM
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HYPERTHYROIDISM
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
ARTHRALGIA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ARTHRITIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BACK PAIN
|
|
|
subjects affected / exposed
|
6 / 1542 (0.39%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BURSITIS
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COSTOCHONDRITIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FASCIITIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FINGER DEFORMITY
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FISTULA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FOOT DEFORMITY
|
|
|
subjects affected / exposed
|
3 / 1542 (0.19%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMARTHROSIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INTERVERTEBRAL DISC DISORDER
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INTERVERTEBRAL DISC PROTRUSION
|
|
|
subjects affected / exposed
|
6 / 1542 (0.39%) |
5 / 1538 (0.33%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
KNEE DEFORMITY
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LIMB DEFORMITY
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LUMBAR SPINAL STENOSIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MORPHOEA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MUSCLE SPASMS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MUSCULOSKELETAL CHEST PAIN
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MYALGIA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
NECK PAIN
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OSTEOARTHRITIS
|
|
|
subjects affected / exposed
|
22 / 1542 (1.43%) |
14 / 1538 (0.91%) |
occurrences causally related to treatment / all
|
0 / 24 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OSTEONECROSIS
|
|
|
subjects affected / exposed
|
4 / 1542 (0.26%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OSTEONECROSIS OF JAW
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OSTEOPOROSIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OSTEOPOROTIC FRACTURE
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PAIN IN EXTREMITY
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PERIARTHRITIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RHEUMATOID ARTHRITIS
|
|
|
subjects affected / exposed
|
15 / 1542 (0.97%) |
12 / 1538 (0.78%) |
occurrences causally related to treatment / all
|
0 / 19 |
2 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
RHEUMATOID NODULE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ROTATOR CUFF SYNDROME
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SPINAL OSTEOARTHRITIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SPONDYLOLISTHESIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SYNOVIAL CYST
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SYNOVITIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
TENOSYNOVITIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
ABSCESS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ABSCESS LIMB
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
6 / 1538 (0.39%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ABSCESS ORAL
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ABSCESS RUPTURE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ACUTE SINUSITIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ANAL ABSCESS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
APPENDICITIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ARTHRITIS BACTERIAL
|
|
|
subjects affected / exposed
|
6 / 1542 (0.39%) |
9 / 1538 (0.59%) |
occurrences causally related to treatment / all
|
5 / 7 |
3 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ARTHRITIS INFECTIVE
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ASPERGILLUS INFECTION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ATYPICAL PNEUMONIA
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BILIARY SEPSIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BRONCHITIS
|
|
|
subjects affected / exposed
|
4 / 1542 (0.26%) |
5 / 1538 (0.33%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BRONCHITIS VIRAL
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BRONCHOPULMONARY ASPERGILLOSIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
BURSITIS INFECTIVE
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CELLULITIS
|
|
|
subjects affected / exposed
|
8 / 1542 (0.52%) |
24 / 1538 (1.56%) |
occurrences causally related to treatment / all
|
5 / 8 |
13 / 26 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CELLULITIS STAPHYLOCOCCAL
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CELLULITIS STREPTOCOCCAL
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CERVICITIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CHRONIC TONSILLITIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CLOSTRIDIUM DIFFICILE COLITIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
CLOSTRIDIUM DIFFICILE INFECTION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COLONIC ABSCESS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DENGUE FEVER
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DEVICE RELATED INFECTION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DEVICE RELATED SEPSIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
DISSEMINATED TUBERCULOSIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
DIVERTICULITIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
10 / 1538 (0.65%) |
occurrences causally related to treatment / all
|
1 / 1 |
5 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
EMPYEMA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ENDOPHTHALMITIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ENTERITIS INFECTIOUS
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
EPIDIDYMITIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
EPIGLOTTITIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ERYSIPELAS
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
11 / 1538 (0.72%) |
occurrences causally related to treatment / all
|
3 / 4 |
3 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ESCHERICHIA PYELONEPHRITIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ESCHERICHIA SEPSIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ESCHERICHIA URINARY TRACT INFECTION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
FUNGAL SKIN INFECTION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROENTERITIS
|
|
|
subjects affected / exposed
|
6 / 1542 (0.39%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
2 / 6 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROENTERITIS NOROVIRUS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GASTROENTERITIS VIRAL
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
GROIN ABSCESS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMATOMA INFECTION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HAEMOPHILUS SEPSIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HERPANGINA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HERPES ZOSTER
|
|
|
subjects affected / exposed
|
4 / 1542 (0.26%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
4 / 4 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INFECTED DERMAL CYST
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INFECTION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INFECTIOUS COLITIS
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INFECTIOUS PLEURAL EFFUSION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INFECTIVE ANEURYSM
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INFLUENZA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INJECTION SITE ABSCESS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
INTERVERTEBRAL DISCITIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LOCALISED INFECTION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LOWER RESPIRATORY TRACT INFECTION
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LUDWIG ANGINA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LUNG ABSCESS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LUNG INFECTION
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
LUNG INFECTION PSEUDOMONAL
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MASTOIDITIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MENINGITIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
MUSCLE ABSCESS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
NASAL ABSCESS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
NEUROSYPHILIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OESOPHAGEAL CANDIDIASIS
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OPHTHALMIC HERPES SIMPLEX
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OPHTHALMIC HERPES ZOSTER
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OSTEOMYELITIS
|
|
|
subjects affected / exposed
|
2 / 1542 (0.13%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
1 / 2 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OSTEOMYELITIS CHRONIC
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
OTITIS EXTERNA
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PAPILLOMA VIRAL INFECTION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PERIHEPATIC ABSCESS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PERITONITIS
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
3 / 1538 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
PERITONSILLAR ABSCESS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PHARYNGITIS
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PNEUMOCYSTIS JIROVECII PNEUMONIA
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
PNEUMONIA
|
|
|
subjects affected / exposed
|
41 / 1542 (2.66%) |
47 / 1538 (3.06%) |
occurrences causally related to treatment / all
|
18 / 46 |
20 / 53 |
deaths causally related to treatment / all
|
0 / 6 |
4 / 8 |
PNEUMONIA BACTERIAL
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
PNEUMONIA INFLUENZAL
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PNEUMONIA MYCOPLASMAL
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PNEUMONIA PNEUMOCOCCAL
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
1 / 1538 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PNEUMONIA STAPHYLOCOCCAL
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
PNEUMONIA VIRAL
|
|
|
subjects affected / exposed
|
1 / 1542 (0.06%) |
0 / 1538 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
POST PROCEDURAL INFECTION
|
|
|
subjects affected / exposed
|
0 / 1542 (0.00%) |
2 / 1538 (0.13%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
|