Serious adverse events
|
All Atrasentan Set |
Double-Blind Placebo |
Double-Blind Atrasentan |
Total subjects affected by serious adverse events
|
|
|
|
subjects affected / exposed
|
292 / 5107 (5.72%) |
626 / 1830 (34.21%) |
685 / 1829 (37.45%) |
number of deaths (all causes)
|
25 |
79 |
84 |
number of deaths resulting from adverse events
|
23 |
64 |
65 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
ACUTE MYELOID LEUKAEMIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
ADENOCARCINOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ADENOCARCINOMA GASTRIC
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ADENOCARCINOMA OF COLON
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
1 / 1830 (0.05%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ADENOCARCINOMA PANCREAS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ADRENAL NEOPLASM
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ATYPICAL FIBROXANTHOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BASAL CELL CARCINOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BENIGN NEOPLASM OF BLADDER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BENIGN NEOPLASM OF THYROID GLAND
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BENIGN RENAL NEOPLASM
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BILE DUCT CANCER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BLADDER CANCER
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
3 / 1830 (0.16%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BLADDER CANCER RECURRENT
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BLADDER CANCER STAGE I, WITH CANCER IN SITU
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BLADDER NEOPLASM
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
3 / 1830 (0.16%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BLADDER TRANSITIONAL CELL CARCINOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
3 / 1830 (0.16%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BONE NEOPLASM
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BRAIN NEOPLASM
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
BRAIN NEOPLASM BENIGN
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BREAST CANCER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BREAST CANCER RECURRENT
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BREAST NEOPLASM
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BRONCHIAL CARCINOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CARCINOID TUMOUR PULMONARY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CHOLANGIOCARCINOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
CHRONIC LYMPHOCYTIC LEUKAEMIA
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
COLON ADENOMA
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
7 / 1829 (0.38%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
COLON CANCER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
COLON NEOPLASM
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
COLORECTAL CANCER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIFFUSE LARGE B-CELL LYMPHOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GALLBLADDER CANCER METASTATIC
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
ENDOMETRIAL CANCER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GASTRIC ADENOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GASTRIC CANCER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
6 / 1830 (0.33%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GLIOBLASTOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GASTROINTESTINAL TRACT ADENOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HEPATIC CANCER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
HEPATOCELLULAR CARCINOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
3 / 1830 (0.16%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HUERTHLE CELL CARCINOMA
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
INFLAMMATORY PSEUDOTUMOUR
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
INTESTINAL ADENOCARCINOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LANGERHANS CELL SARCOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
INTRADUCTAL PROLIFERATIVE BREAST LESION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LIPOSARCOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LIPOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LARYNGEAL SQUAMOUS CELL CARCINOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LUNG ADENOCARCINOMA STAGE IV
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
LUNG ADENOCARCINOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LUNG NEOPLASM MALIGNANT
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LUNG NEOPLASM
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LUNG CANCER METASTATIC
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
MALIGNANT PALATE NEOPLASM
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LYMPHOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
METASTATIC CARCINOMA OF THE BLADDER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
METASTATIC MALIGNANT MELANOMA
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
METASTATIC NEOPLASM
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MUCINOUS ADENOCARCINOMA OF APPENDIX
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
NASOPHARYNGEAL CANCER
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
NEUROENDOCRINE CARCINOMA
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
OESOPHAGEAL CARCINOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
NEUROENDOCRINE TUMOUR OF THE LUNG
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
OESOPHAGEAL SQUAMOUS CELL CARCINOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
OROPHARYNGEAL NEOPLASM
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
OSTEOSARCOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
OVARIAN CANCER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
OVARIAN ADENOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PITUITARY TUMOUR BENIGN
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PANCREATIC CARCINOMA METASTATIC
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
PANCREATIC CARCINOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PROSTATE CANCER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
7 / 1830 (0.38%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PLASMA CELL MYELOMA
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
PROSTATE CANCER RECURRENT
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PSEUDOMYXOMA PERITONEI
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PROSTATIC ADENOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
RECTAL ADENOCARCINOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
3 / 1830 (0.16%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
RENAL CANCER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
RENAL CELL CARCINOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
RENAL CANCER METASTATIC
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
RENAL ONCOCYTOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SINONASAL PAPILLOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SQUAMOUS CELL CARCINOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SMALL CELL LUNG CANCER METASTATIC
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
SQUAMOUS CELL CARCINOMA OF THE HYPOPHARYNX
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
SQUAMOUS CELL CARCINOMA OF LUNG
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
SQUAMOUS CELL CARCINOMA OF THE ORAL CAVITY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
TRANSITIONAL CELL CARCINOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
THYROID NEOPLASM
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
TRANSITIONAL CELL CARCINOMA RECURRENT
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
UTERINE LEIOMYOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
ANEURYSM
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
AORTIC ANEURYSM
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
AORTIC STENOSIS
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
3 / 1830 (0.16%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
AORTIC ANEURYSM RUPTURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
ARTERIOSCLEROSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
ARTERIAL STENOSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ARTERIAL DISORDER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BLOOD PRESSURE INADEQUATELY CONTROLLED
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ARTERITIS
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIABETIC VASCULAR DISORDER
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DEEP VEIN THROMBOSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
4 / 1830 (0.22%) |
4 / 1829 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DRY GANGRENE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
EXTREMITY NECROSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HAEMATOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPERTENSION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
9 / 1830 (0.49%) |
9 / 1829 (0.49%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 9 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPERTENSIVE CRISIS
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
4 / 1830 (0.22%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPERTENSIVE EMERGENCY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPOVOLAEMIC SHOCK
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPOTENSION
|
|
|
|
subjects affected / exposed
|
4 / 5107 (0.08%) |
4 / 1830 (0.22%) |
4 / 1829 (0.22%) |
occurrences causally related to treatment / all
|
4 / 5 |
1 / 4 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
7 / 1830 (0.38%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 10 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MALIGNANT HYPERTENSION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ORTHOSTATIC HYPOTENSION
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
2 / 1830 (0.11%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PERIPHERAL ARTERY STENOSIS
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
2 / 1830 (0.11%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PERIPHERAL ARTERY OCCLUSION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PERIPHERAL ARTERY THROMBOSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PERIPHERAL VASCULAR DISORDER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PERIPHERAL ISCHAEMIA
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
2 / 1830 (0.11%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SHOCK HAEMORRHAGIC
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
PERIPHERAL VENOUS DISEASE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SUBCLAVIAN ARTERY OCCLUSION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
THROMBOPHLEBITIS
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
VASCULAR OCCLUSION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
BRAIN DEATH
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
ASTHENIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CHEST DISCOMFORT
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CHEST PAIN
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
4 / 1830 (0.22%) |
7 / 1829 (0.38%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 4 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CHILLS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DEATH
|
|
|
|
subjects affected / exposed
|
3 / 5107 (0.06%) |
4 / 1830 (0.22%) |
5 / 1829 (0.27%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 4 |
1 / 5 |
deaths causally related to treatment / all
|
2 / 3 |
0 / 4 |
1 / 5 |
DISEASE COMPLICATION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
FACE OEDEMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
FATIGUE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
FEELING ABNORMAL
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GENERAL PHYSICAL HEALTH DETERIORATION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GENERALISED OEDEMA
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
3 / 1830 (0.16%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPOTHERMIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
IMPAIRED HEALING
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
INFLUENZA LIKE ILLNESS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MULTIPLE ORGAN DYSFUNCTION SYNDROME
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
3 / 1830 (0.16%) |
5 / 1829 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 4 |
NECROSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
NON-CARDIAC CHEST PAIN
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
3 / 1830 (0.16%) |
4 / 1829 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
OEDEMA PERIPHERAL
|
|
|
|
subjects affected / exposed
|
4 / 5107 (0.08%) |
3 / 1830 (0.16%) |
6 / 1829 (0.33%) |
occurrences causally related to treatment / all
|
3 / 4 |
3 / 3 |
3 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PERIPHERAL SWELLING
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PYREXIA
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
2 / 1830 (0.11%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SUDDEN CARDIAC DEATH
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
SUDDEN DEATH
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
5 / 1830 (0.27%) |
8 / 1829 (0.44%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 5 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
2 / 5 |
1 / 8 |
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ULCER HAEMORRHAGE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
VASCULAR STENT STENOSIS
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
ALLERGY TO ARTHROPOD BITE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ANAPHYLACTIC SHOCK
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DRUG HYPERSENSITIVITY
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPERSENSITIVITY
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Social circumstances
|
|
|
|
OVERWORK
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
BENIGN PROSTATIC HYPERPLASIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
7 / 1830 (0.38%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
EPIDIDYMAL CYST
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GYNAECOMASTIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PROSTATITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SCROTAL OEDEMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
UTERINE PROLAPSE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
ACUTE PULMONARY OEDEMA
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
6 / 1830 (0.33%) |
5 / 1829 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 6 |
3 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
1 / 2 |
ACUTE RESPIRATORY DISTRESS SYNDROME
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ACUTE RESPIRATORY FAILURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
9 / 1830 (0.49%) |
11 / 1829 (0.60%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 9 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ASPIRATION
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
ASTHMA
|
|
|
|
subjects affected / exposed
|
3 / 5107 (0.06%) |
3 / 1830 (0.16%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
BRONCHOSPASM
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
|
|
|
subjects affected / exposed
|
3 / 5107 (0.06%) |
6 / 1830 (0.33%) |
9 / 1829 (0.49%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
COUGH
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DYSPNOEA
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
3 / 1830 (0.16%) |
5 / 1829 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
2 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DYSPNOEA EXERTIONAL
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
EPISTAXIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HAEMOPTYSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HAEMOTHORAX
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYDROTHORAX
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPERCAPNIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPOVENTILATION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPOXIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
INTERSTITIAL LUNG DISEASE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MEDIASTINAL CYST
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
OBSTRUCTIVE AIRWAYS DISORDER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PLEURAL EFFUSION
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
2 / 1830 (0.11%) |
7 / 1829 (0.38%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PNEUMOMEDIASTINUM
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PNEUMONIA ASPIRATION
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
6 / 1829 (0.33%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PNEUMOTHORAX
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PULMONARY CONGESTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PULMONARY EMBOLISM
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
2 / 1830 (0.11%) |
4 / 1829 (0.22%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
PULMONARY HYPERTENSION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PULMONARY MASS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PULMONARY OEDEMA
|
|
|
|
subjects affected / exposed
|
6 / 5107 (0.12%) |
4 / 1830 (0.22%) |
7 / 1829 (0.38%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 5 |
2 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
RESPIRATORY ARREST
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
RESPIRATORY DISTRESS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
5 / 1829 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
RESPIRATORY FAILURE
|
|
|
|
subjects affected / exposed
|
3 / 5107 (0.06%) |
8 / 1830 (0.44%) |
6 / 1829 (0.33%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 2 |
1 / 4 |
0 / 1 |
RESTRICTIVE PULMONARY DISEASE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SLEEP APNOEA SYNDROME
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
AGITATION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ANXIETY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BIPOLAR DISORDER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CONFUSIONAL STATE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DELIRIUM
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DELUSIONAL DISORDER, SOMATIC TYPE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DEPRESSION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DISORIENTATION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DRUG ABUSE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
INSOMNIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MENTAL STATUS CHANGES
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MAJOR DEPRESSION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SUICIDAL IDEATION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Product issues
|
|
|
|
Device capturing issue
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device dislocation
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
BILE DUCT STONE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
3 / 1830 (0.16%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BILIARY COLIC
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CHOLANGITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CHOLECYSTITIS
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
2 / 1830 (0.11%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CHOLECYSTITIS ACUTE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
3 / 1830 (0.16%) |
6 / 1829 (0.33%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CHOLECYSTITIS CHRONIC
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CHOLELITHIASIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
3 / 1830 (0.16%) |
5 / 1829 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DRUG-INDUCED LIVER INJURY
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GALLBLADDER PERFORATION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HEPATIC CIRRHOSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HEPATIC LESION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HEPATIC STEATOSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HEPATITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HEPATITIS ACUTE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
BLOOD ALKALINE PHOSPHATASE INCREASED
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BLOOD BICARBONATE DECREASED
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BLOOD CREATININE INCREASED
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
7 / 1830 (0.38%) |
5 / 1829 (0.27%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BLOOD GLUCOSE DECREASED
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BLOOD POTASSIUM INCREASED
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BLOOD UREA INCREASED
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BRAIN NATRIURETIC PEPTIDE INCREASED
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ELECTROCARDIOGRAM Q WAVE ABNORMAL
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GLOMERULAR FILTRATION RATE DECREASED
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HAEMOGLOBIN DECREASED
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HELICOBACTER TEST POSITIVE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HEPATIC ENZYME INCREASED
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LIPASE INCREASED
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
INTRAOCULAR PRESSURE INCREASED
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PROSTATIC SPECIFIC ANTIGEN INCREASED
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PROTEIN URINE PRESENT
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
TROPONIN INCREASED
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
URINE CYTOLOGY ABNORMAL
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
WEIGHT INCREASED
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
ABDOMINAL INJURY
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ANKLE FRACTURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ABDOMINAL WOUND DEHISCENCE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BRAIN CONTUSION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BLADDER INJURY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BURNS SECOND DEGREE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CERVICAL VERTEBRAL FRACTURE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CLAVICLE FRACTURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CONCUSSION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
3 / 1830 (0.16%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CONTUSION
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
2 / 1830 (0.11%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CYSTITIS RADIATION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CRANIOCEREBRAL INJURY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DISLOCATION OF VERTEBRA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
FACIAL BONES FRACTURE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
FALL
|
|
|
|
subjects affected / exposed
|
7 / 5107 (0.14%) |
5 / 1830 (0.27%) |
12 / 1829 (0.66%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
FEMORAL NECK FRACTURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
3 / 1830 (0.16%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
FIBULA FRACTURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
FEMUR FRACTURE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
3 / 1830 (0.16%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
FOOT FRACTURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
FOREIGN BODY IN GASTROINTESTINAL TRACT
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GRAFT THROMBOSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HAND FRACTURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HEAD INJURY
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
3 / 1830 (0.16%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HIP FRACTURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HUMERUS FRACTURE
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
2 / 1830 (0.11%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ILIUM FRACTURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
INCISIONAL HERNIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
INJURY
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
JAW FRACTURE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
JOINT DISLOCATION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LACERATION
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LIGAMENT SPRAIN
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LIMB INJURY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LIMB TRAUMATIC AMPUTATION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LISFRANC FRACTURE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LOWER LIMB FRACTURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LUMBAR VERTEBRAL FRACTURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
4 / 1830 (0.22%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MENISCUS INJURY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MULTIPLE FRACTURES
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MUSCLE RUPTURE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
OVERDOSE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PANCREATIC LEAK
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PATELLA FRACTURE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PELVIC FRACTURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
POST CONCUSSION SYNDROME
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
POST PROCEDURAL DISCHARGE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
POST PROCEDURAL HAEMATOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
POST PROCEDURAL HAEMORRHAGE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
2 / 1830 (0.11%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
POST PROCEDURAL SWELLING
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
POSTOPERATIVE WOUND COMPLICATION
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PROCEDURAL PAIN
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PUBIS FRACTURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
RADIUS FRACTURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
RIB FRACTURE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ROAD TRAFFIC ACCIDENT
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
SPINAL COMPRESSION FRACTURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SKIN ABRASION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SPINAL CORD INJURY CERVICAL
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SPINAL FRACTURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SUBARACHNOID HAEMORRHAGE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SUBDURAL HAEMATOMA
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
2 / 1830 (0.11%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SUBDURAL HAEMORRHAGE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
TENDON RUPTURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
THERMAL BURN
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
THORACIC VERTEBRAL FRACTURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
TIBIA FRACTURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
TOXICITY TO VARIOUS AGENTS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
TRAUMATIC FRACTURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
TRAUMATIC HAEMATOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
TRAUMATIC HAEMOTHORAX
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
TRAUMATIC LUNG INJURY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ULNA FRACTURE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ULNAR NERVE INJURY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
URINARY RETENTION POSTOPERATIVE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
VASCULAR PSEUDOANEURYSM
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
WOUND
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
WOUND COMPLICATION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
WOUND DEHISCENCE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
WOUND HAEMORRHAGE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
WOUND NECROSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
|
GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
ACUTE CORONARY SYNDROME
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
2 / 1830 (0.11%) |
5 / 1829 (0.27%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ACUTE LEFT VENTRICULAR FAILURE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
3 / 1830 (0.16%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 4 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ACUTE MYOCARDIAL INFARCTION
|
|
|
|
subjects affected / exposed
|
7 / 5107 (0.14%) |
28 / 1830 (1.53%) |
34 / 1829 (1.86%) |
occurrences causally related to treatment / all
|
1 / 7 |
1 / 29 |
4 / 40 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 2 |
ADAMS-STOKES SYNDROME
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ANGINA PECTORIS
|
|
|
|
subjects affected / exposed
|
4 / 5107 (0.08%) |
10 / 1830 (0.55%) |
10 / 1829 (0.55%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 10 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ANGINA UNSTABLE
|
|
|
|
subjects affected / exposed
|
4 / 5107 (0.08%) |
3 / 1830 (0.16%) |
7 / 1829 (0.38%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
AORTIC VALVE STENOSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ARRHYTHMIA SUPRAVENTRICULAR
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ARRHYTHMIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
ARTERIOSCLEROSIS CORONARY ARTERY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
ATRIAL FIBRILLATION
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
10 / 1830 (0.55%) |
16 / 1829 (0.87%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 11 |
4 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ATRIAL FLUTTER
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
2 / 1830 (0.11%) |
5 / 1829 (0.27%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
2 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ATRIAL TACHYCARDIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ATRIOVENTRICULAR BLOCK
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ATRIOVENTRICULAR BLOCK COMPLETE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
2 / 1830 (0.11%) |
7 / 1829 (0.38%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ATRIOVENTRICULAR BLOCK FIRST DEGREE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ATRIOVENTRICULAR BLOCK SECOND DEGREE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BRADYARRHYTHMIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BRADYCARDIA
|
|
|
|
subjects affected / exposed
|
3 / 5107 (0.06%) |
2 / 1830 (0.11%) |
4 / 1829 (0.22%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BUNDLE BRANCH BLOCK BILATERAL
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BUNDLE BRANCH BLOCK RIGHT
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BUNDLE BRANCH BLOCK LEFT
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CARDIAC ARREST
|
|
|
|
subjects affected / exposed
|
3 / 5107 (0.06%) |
5 / 1830 (0.27%) |
4 / 1829 (0.22%) |
occurrences causally related to treatment / all
|
1 / 3 |
1 / 5 |
1 / 4 |
deaths causally related to treatment / all
|
1 / 3 |
1 / 5 |
1 / 3 |
CARDIAC FAILURE
|
|
|
|
subjects affected / exposed
|
5 / 5107 (0.10%) |
11 / 1830 (0.60%) |
19 / 1829 (1.04%) |
occurrences causally related to treatment / all
|
4 / 5 |
5 / 11 |
6 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
CARDIAC FAILURE ACUTE
|
|
|
|
subjects affected / exposed
|
4 / 5107 (0.08%) |
4 / 1830 (0.22%) |
5 / 1829 (0.27%) |
occurrences causally related to treatment / all
|
2 / 4 |
0 / 5 |
4 / 6 |
deaths causally related to treatment / all
|
1 / 2 |
0 / 1 |
1 / 1 |
CARDIAC FAILURE CHRONIC
|
|
|
|
subjects affected / exposed
|
3 / 5107 (0.06%) |
2 / 1830 (0.11%) |
5 / 1829 (0.27%) |
occurrences causally related to treatment / all
|
2 / 3 |
1 / 2 |
1 / 5 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
CARDIAC FAILURE CONGESTIVE
|
|
|
|
subjects affected / exposed
|
22 / 5107 (0.43%) |
22 / 1830 (1.20%) |
37 / 1829 (2.02%) |
occurrences causally related to treatment / all
|
17 / 22 |
7 / 23 |
15 / 41 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
CARDIO-RESPIRATORY ARREST
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 3 |
CARDIOGENIC SHOCK
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
CARDIOMYOPATHY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
CARDIOPULMONARY FAILURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
CARDIORENAL SYNDROME
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CARDIOVASCULAR DISORDER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CHRONIC LEFT VENTRICULAR FAILURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CORONARY ARTERY DISEASE
|
|
|
|
subjects affected / exposed
|
6 / 5107 (0.12%) |
19 / 1830 (1.04%) |
29 / 1829 (1.59%) |
occurrences causally related to treatment / all
|
1 / 6 |
1 / 20 |
3 / 31 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
CORONARY ARTERY OCCLUSION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
3 / 1830 (0.16%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CORONARY ARTERY STENOSIS
|
|
|
|
subjects affected / exposed
|
3 / 5107 (0.06%) |
2 / 1830 (0.11%) |
5 / 1829 (0.27%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CORONARY ARTERY THROMBOSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
CYANOSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIASTOLIC DYSFUNCTION
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPERTENSIVE CARDIOMYOPATHY
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPERTENSIVE HEART DISEASE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
ISCHAEMIC CARDIOMYOPATHY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LEFT VENTRICULAR FAILURE
|
|
|
|
subjects affected / exposed
|
3 / 5107 (0.06%) |
1 / 1830 (0.05%) |
4 / 1829 (0.22%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 1 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MITRAL VALVE INCOMPETENCE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MYOCARDIAL INFARCTION
|
|
|
|
subjects affected / exposed
|
7 / 5107 (0.14%) |
8 / 1830 (0.44%) |
13 / 1829 (0.71%) |
occurrences causally related to treatment / all
|
3 / 7 |
0 / 8 |
4 / 15 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
MYOCARDIAL ISCHAEMIA
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
4 / 1830 (0.22%) |
9 / 1829 (0.49%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PALPITATIONS
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
2 / 1830 (0.11%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PERICARDIAL EFFUSION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
4 / 1829 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
SINOATRIAL BLOCK
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SINUS ARREST
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SINUS NODE DYSFUNCTION
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
2 / 1830 (0.11%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SUPRAVENTRICULAR TACHYCARDIA
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
TACHYCARDIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
VENTRICULAR EXTRASYSTOLES
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
VENTRICULAR FIBRILLATION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
VENTRICULAR TACHYCARDIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
|
ALTERED STATE OF CONSCIOUSNESS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ACUTE MOTOR AXONAL NEUROPATHY
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
APHASIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BALANCE DISORDER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CAROTID ARTERY OCCLUSION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BRAIN STEM INFARCTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CAROTID ARTERY STENOSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
3 / 1830 (0.16%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CARPAL TUNNEL SYNDROME
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CEREBELLAR HAEMATOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CEREBELLAR INFARCTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CEREBRAL HAEMORRHAGE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
CEREBRAL INFARCTION
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
8 / 1830 (0.44%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 9 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
CEREBRAL ISCHAEMIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CEREBRAL THROMBOSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CEREBROVASCULAR ACCIDENT
|
|
|
|
subjects affected / exposed
|
5 / 5107 (0.10%) |
14 / 1830 (0.77%) |
13 / 1829 (0.71%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 14 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
CEREBROVASCULAR DISORDER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CERVICOBRACHIAL SYNDROME
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
COMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
DEMENTIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIABETIC COMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIABETIC HYPERGLYCAEMIC COMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIABETIC HYPEROSMOLAR COMA
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIABETIC NEUROPATHY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIZZINESS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
3 / 1830 (0.16%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
EMBOLIC CEREBRAL INFARCTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ENCEPHALOPATHY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
FACIAL PARALYSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HEADACHE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HAEMORRHAGIC STROKE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
3 / 1830 (0.16%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
HEMIPARESIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYDROCEPHALUS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPERTENSIVE ENCEPHALOPATHY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPOGLYCAEMIC SEIZURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ISCHAEMIC STROKE
|
|
|
|
subjects affected / exposed
|
3 / 5107 (0.06%) |
9 / 1830 (0.49%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 10 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
ISCHAEMIC CEREBRAL INFARCTION
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
IVTH NERVE PARALYSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LACUNAR INFARCTION
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
2 / 1830 (0.11%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LOSS OF CONSCIOUSNESS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LUMBAR RADICULOPATHY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
METABOLIC ENCEPHALOPATHY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MIGRAINE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MONONEUROPATHY MULTIPLEX
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MYELOPATHY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MYOCLONUS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
NEUROPATHY PERIPHERAL
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PARAESTHESIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PRESYNCOPE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
QUADRIPLEGIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
RADICULOPATHY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SCIATICA
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SEIZURE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
4 / 1829 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SENILE DEMENTIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SPINAL CORD DISORDER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SPONDYLITIC MYELOPATHY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
STATUS EPILEPTICUS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SYNCOPE
|
|
|
|
subjects affected / exposed
|
3 / 5107 (0.06%) |
11 / 1830 (0.60%) |
6 / 1829 (0.33%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 11 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
THALAMIC INFARCTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
TRANSIENT ISCHAEMIC ATTACK
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
7 / 1830 (0.38%) |
7 / 1829 (0.38%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
VASCULAR DEMENTIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
ANAEMIA
|
|
|
|
subjects affected / exposed
|
7 / 5107 (0.14%) |
11 / 1830 (0.60%) |
27 / 1829 (1.48%) |
occurrences causally related to treatment / all
|
2 / 7 |
1 / 15 |
3 / 28 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ANAEMIA OF CHRONIC DISEASE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
AUTOIMMUNE HAEMOLYTIC ANAEMIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
COAGULOPATHY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DISSEMINATED INTRAVASCULAR COAGULATION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HAEMORRHAGIC ANAEMIA
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
IRON DEFICIENCY ANAEMIA
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
2 / 1830 (0.11%) |
4 / 1829 (0.22%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LEUKOCYTOSIS
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MICROCYTIC ANAEMIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
NEPHROGENIC ANAEMIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
NEUTROPENIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
PANCYTOPENIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
THROMBOCYTOPENIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
|
MENIERE'S DISEASE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
VERTIGO
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
7 / 1830 (0.38%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 7 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
VERTIGO POSITIONAL
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
AGE-RELATED MACULAR DEGENERATION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ANGLE CLOSURE GLAUCOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BLINDNESS TRANSIENT
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CATARACT
|
|
|
|
subjects affected / exposed
|
3 / 5107 (0.06%) |
10 / 1830 (0.55%) |
19 / 1829 (1.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 12 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CATARACT DIABETIC
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CATARACT NUCLEAR
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CORNEAL EPITHELIUM DEFECT
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CORNEAL OPACITY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DACRYOSTENOSIS ACQUIRED
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIABETIC RETINOPATHY
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
0 / 1830 (0.00%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIPLOPIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
EYE HAEMORRHAGE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
EYELID PTOSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GLAUCOMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LAGOPHTHALMOS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MACULAR FIBROSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MACULAR OEDEMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
OPTIC ISCHAEMIC NEUROPATHY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PERIORBITAL OEDEMA
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
RETINAL DETACHMENT
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
RETINAL HAEMORRHAGE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
RETINOPATHY PROLIFERATIVE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
RHEGMATOGENOUS RETINAL DETACHMENT
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
TRACTIONAL RETINAL DETACHMENT
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
VISUAL IMPAIRMENT
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
VITREOUS ADHESIONS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
VITREOUS HAEMORRHAGE
|
|
|
|
subjects affected / exposed
|
4 / 5107 (0.08%) |
5 / 1830 (0.27%) |
9 / 1829 (0.49%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
ABDOMINAL DISTENSION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ABDOMINAL HERNIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ABDOMINAL PAIN
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
2 / 1830 (0.11%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ANAL INCONTINENCE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ANORECTAL ULCER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ASCITES
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CHRONIC GASTRITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
COLITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
COLITIS ULCERATIVE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CONSTIPATION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DENTAL CARIES
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIABETIC GASTROPARESIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIABETIC GASTROPATHY
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIARRHOEA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
3 / 1830 (0.16%) |
4 / 1829 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIVERTICULUM
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIVERTICULUM INTESTINAL HAEMORRHAGIC
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DUODENAL ULCER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DUODENAL ULCER HAEMORRHAGE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DUODENITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DYSPHAGIA
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
2 / 1830 (0.11%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ENTEROVESICAL FISTULA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
EROSIVE DUODENITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GASTRIC DISORDER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GASTRIC FISTULA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GASTRIC MUCOSAL HYPERTROPHY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GASTRIC POLYPS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GASTRIC ULCER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GASTRIC ULCER HAEMORRHAGE
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
3 / 1830 (0.16%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GASTRITIS
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GASTRITIS HAEMORRHAGIC
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GASTROINTESTINAL HAEMORRHAGE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
3 / 1830 (0.16%) |
6 / 1829 (0.33%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GASTROINTESTINAL MUCOSAL DISORDER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GASTROOESOPHAGEAL REFLUX DISEASE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
2 / 1830 (0.11%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HAEMORRHOIDS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HIATUS HERNIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ILEUS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
IMPAIRED GASTRIC EMPTYING
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
INGUINAL HERNIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
INTESTINAL HAEMORRHAGE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
INTESTINAL OBSTRUCTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
INTESTINAL PERFORATION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
IRRITABLE BOWEL SYNDROME
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LARGE INTESTINE PERFORATION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LARGE INTESTINE POLYP
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
2 / 1830 (0.11%) |
7 / 1829 (0.38%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LOWER GASTROINTESTINAL HAEMORRHAGE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LYMPHOCYTIC OESOPHAGITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MELAENA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
NAUSEA
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
1 / 1830 (0.05%) |
4 / 1829 (0.22%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
OBSTRUCTIVE PANCREATITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
OESOPHAGEAL SPASM
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
OESOPHAGEAL ULCER HAEMORRHAGE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
OESOPHAGITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PANCREATIC DISORDER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PANCREATITIS
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
4 / 1830 (0.22%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
PANCREATITIS ACUTE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
4 / 1830 (0.22%) |
5 / 1829 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PEPTIC ULCER HAEMORRHAGE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PEPTIC ULCER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PROCTITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
RECTAL HAEMORRHAGE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
RECTAL ULCER HAEMORRHAGE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
RECTAL POLYP
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SMALL INTESTINAL OBSTRUCTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
UMBILICAL HERNIA
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ULCERATIVE GASTRITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
UPPER GASTROINTESTINAL HAEMORRHAGE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
3 / 1830 (0.16%) |
5 / 1829 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
VOMITING
|
|
|
|
subjects affected / exposed
|
3 / 5107 (0.06%) |
5 / 1830 (0.27%) |
7 / 1829 (0.38%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
ACTINIC KERATOSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ANGIOEDEMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIABETIC CHEIROARTHROPATHY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DECUBITUS ULCER
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIABETIC FOOT
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
10 / 1830 (0.55%) |
8 / 1829 (0.44%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 10 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ECZEMA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
INGROWING NAIL
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PRURITUS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SKIN DISCOLOURATION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SKIN ULCER
|
|
|
|
subjects affected / exposed
|
4 / 5107 (0.08%) |
3 / 1830 (0.16%) |
5 / 1829 (0.27%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
ACUTE KIDNEY INJURY
|
|
|
|
subjects affected / exposed
|
19 / 5107 (0.37%) |
36 / 1830 (1.97%) |
54 / 1829 (2.95%) |
occurrences causally related to treatment / all
|
3 / 20 |
7 / 40 |
4 / 56 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
AZOTAEMIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
BLADDER STENOSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CALCULUS URINARY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CHRONIC KIDNEY DISEASE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
13 / 1830 (0.71%) |
9 / 1829 (0.49%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 13 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIABETIC NEPHROPATHY
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
10 / 1830 (0.55%) |
17 / 1829 (0.93%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 11 |
1 / 23 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
END STAGE RENAL DISEASE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
27 / 1830 (1.48%) |
19 / 1829 (1.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 30 |
1 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GLOMERULONEPHRITIS MEMBRANOUS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HAEMATURIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HAEMORRHAGE URINARY TRACT
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYDRONEPHROSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYDROURETER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
NEPHROLITHIASIS
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
4 / 1829 (0.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
NEPHROPATHY TOXIC
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PROTEINURIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
RENAL ARTERY STENOSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
RENAL FAILURE
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
5 / 1830 (0.27%) |
5 / 1829 (0.27%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
RENAL IMPAIRMENT
|
|
|
|
subjects affected / exposed
|
3 / 5107 (0.06%) |
13 / 1830 (0.71%) |
10 / 1829 (0.55%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 14 |
1 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
URETERIC OBSTRUCTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
RENAL VASCULITIS
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
URETHRAL STENOSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
URETEROLITHIASIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
URINARY BLADDER POLYP
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
URINARY RETENTION
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
5 / 1829 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
URINARY TRACT OBSTRUCTION
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
|
GOITRE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPERPARATHYROIDISM PRIMARY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
ARTHRALGIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
3 / 1830 (0.16%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ARTHRITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
4 / 1829 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ARTHROPATHY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CHRONIC KIDNEY DISEASE-MINERAL AND BONE DISORDER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CERVICAL SPINAL STENOSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BACK PAIN
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
4 / 1830 (0.22%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
COMPARTMENT SYNDROME
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
COSTOCHONDRITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HAEMARTHROSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GOUTY ARTHRITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
4 / 1830 (0.22%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
INTERVERTEBRAL DISC DEGENERATION
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
INTERVERTEBRAL DISC DISORDER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
INTERVERTEBRAL DISC DISPLACEMENT
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
INTERVERTEBRAL DISC PROTRUSION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
4 / 1830 (0.22%) |
4 / 1829 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LUMBAR SPINAL STENOSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
3 / 1830 (0.16%) |
5 / 1829 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
JOINT SWELLING
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MENISCAL DEGENERATION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MOBILITY DECREASED
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MUSCULAR WEAKNESS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MYALGIA
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MUSCULOSKELETAL CHEST PAIN
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
5 / 1830 (0.27%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
NECK PAIN
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
NEUROPATHIC ARTHROPATHY
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
OSTEOARTHRITIS
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
16 / 1830 (0.87%) |
8 / 1829 (0.44%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 19 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
OSTEITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
OSTEOPOROSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PAIN IN EXTREMITY
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
POLYARTHRITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
RHABDOMYOLYSIS
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ROTATOR CUFF SYNDROME
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SACROILIITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SOFT TISSUE NECROSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SPINAL COLUMN STENOSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SPINAL INSTABILITY
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SPINAL LIGAMENT OSSIFICATION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SPINAL OSTEOARTHRITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SPONDYLITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SPONDYLOLISTHESIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SYMPATHETIC POSTERIOR CERVICAL SYNDROME
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SYNOVIAL CYST
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SYNOVITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
THORACIC SPINAL STENOSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
TORTICOLLIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
ABDOMINAL ABSCESS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ABSCESS LIMB
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
6 / 1830 (0.33%) |
6 / 1829 (0.33%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ABSCESS SOFT TISSUE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ACUTE SINUSITIS
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ANAL ABSCESS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
APPENDICITIS
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
3 / 1830 (0.16%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ARTERIOSCLEROTIC GANGRENE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ARTHRITIS BACTERIAL
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ARTHRITIS INFECTIVE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BACTERAEMIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BACTERIAL DIARRHOEA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BACTERIAL SEPSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BILIARY SEPSIS
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BRAIN ABSCESS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BRONCHITIS
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
4 / 1830 (0.22%) |
9 / 1829 (0.49%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BRONCHITIS BACTERIAL
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CAMPYLOBACTER GASTROENTERITIS
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CAMPYLOBACTER INFECTION
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CELLULITIS
|
|
|
|
subjects affected / exposed
|
5 / 5107 (0.10%) |
22 / 1830 (1.20%) |
14 / 1829 (0.77%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 24 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CELLULITIS GANGRENOUS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CHOLECYSTITIS INFECTIVE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CLOSTRIDIAL SEPSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CHRONIC TONSILLITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CLOSTRIDIUM DIFFICILE INFECTION
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CLOSTRIDIUM DIFFICILE COLITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CYSTITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CYSTITIS KLEBSIELLA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DENGUE FEVER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DEVICE RELATED INFECTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIABETIC FOOT INFECTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIVERTICULITIS
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
4 / 1830 (0.22%) |
4 / 1829 (0.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIABETIC GANGRENE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
3 / 1830 (0.16%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
EMPHYSEMATOUS PYELONEPHRITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ENDOCARDITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ENDOPHTHALMITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ENTERITIS INFECTIOUS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ENTEROBACTER INFECTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ERYSIPELAS
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
3 / 1830 (0.16%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ENTEROCOCCAL INFECTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ESCHERICHIA INFECTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ESCHERICHIA BACTERAEMIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ESCHERICHIA SEPSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
ESCHERICHIA URINARY TRACT INFECTION
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GANGRENE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
7 / 1830 (0.38%) |
4 / 1829 (0.22%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GAS GANGRENE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GASTROENTERITIS
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
10 / 1830 (0.55%) |
8 / 1829 (0.44%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 10 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GASTROENTERITIS VIRAL
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GRAFT INFECTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HELICOBACTER INFECTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HEPATITIS B
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HEPATITIS C
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HERPES ZOSTER
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
INFECTED SKIN ULCER
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
INFECTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
INFECTIVE EXACERBATION OF BRONCHIECTASIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
INFLUENZA
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
INTERVERTEBRAL DISCITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
JOINT ABSCESS
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
KLEBSIELLA INFECTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LEPTOSPIROSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LIVER ABSCESS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LOCALISED INFECTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LOWER RESPIRATORY TRACT INFECTION
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
1 / 1830 (0.05%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
LUNG INFECTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
3 / 1830 (0.16%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MASTOIDITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MEDICAL DEVICE SITE INFECTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
MORGANELLA INFECTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
NASOPHARYNGITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
NECROTISING FASCIITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
NEUTROPENIC SEPSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
NOSOCOMIAL INFECTION
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ORCHITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
OSTEOMYELITIS
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
10 / 1830 (0.55%) |
9 / 1829 (0.49%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 11 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
OSTEOMYELITIS ACUTE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
OSTEOMYELITIS CHRONIC
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
OTITIS EXTERNA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
OTITIS MEDIA ACUTE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
OTITIS MEDIA CHRONIC
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PANCREATITIS BACTERIAL
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PAROTID ABSCESS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PERIODONTITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PERIRECTAL ABSCESS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PERITONITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
3 / 1830 (0.16%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
PERITONSILLAR ABSCESS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PHARYNGEAL ABSCESS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PILONIDAL CYST
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PNEUMONIA
|
|
|
|
subjects affected / exposed
|
14 / 5107 (0.27%) |
41 / 1830 (2.24%) |
54 / 1829 (2.95%) |
occurrences causally related to treatment / all
|
0 / 14 |
3 / 43 |
2 / 63 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
PNEUMONIA BACTERIAL
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
4 / 1829 (0.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PNEUMONIA LEGIONELLA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PNEUMONIA PARAINFLUENZAE VIRAL
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PNEUMONIA PSEUDOMONAL
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PNEUMONIA STAPHYLOCOCCAL
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PNEUMONIA STREPTOCOCCAL
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PNEUMONIA VIRAL
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
POST PROCEDURAL CELLULITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
POST PROCEDURAL INFECTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
POSTOPERATIVE ABSCESS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
POSTOPERATIVE WOUND INFECTION
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PROSTATIC ABSCESS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PROSTATITIS ESCHERICHIA COLI
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PSEUDOMONAS INFECTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PULMONARY TUBERCULOMA
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PYELONEPHRITIS
|
|
|
|
subjects affected / exposed
|
3 / 5107 (0.06%) |
4 / 1830 (0.22%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PYELONEPHRITIS ACUTE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
4 / 1830 (0.22%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
PYELONEPHRITIS CHRONIC
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
RESPIRATORY TRACT INFECTION
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
RHINITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SEPSIS
|
|
|
|
subjects affected / exposed
|
4 / 5107 (0.08%) |
18 / 1830 (0.98%) |
16 / 1829 (0.87%) |
occurrences causally related to treatment / all
|
0 / 4 |
2 / 18 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
SEPSIS SYNDROME
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SEPTIC EMBOLUS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SEPTIC ENCEPHALOPATHY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SEPTIC NECROSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SEPTIC SHOCK
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
6 / 1830 (0.33%) |
5 / 1829 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
SIALOADENITIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
STAPHYLOCOCCAL ABSCESS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
STAPHYLOCOCCAL BACTERAEMIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
STAPHYLOCOCCAL SEPSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
STREPTOCOCCAL BACTERAEMIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SYSTEMIC CANDIDA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
TOOTH ABSCESS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
TOXIC SHOCK SYNDROME
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
UPPER RESPIRATORY TRACT INFECTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
TUBERCULOSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
URINARY TRACT INFECTION
|
|
|
|
subjects affected / exposed
|
6 / 5107 (0.12%) |
12 / 1830 (0.66%) |
21 / 1829 (1.15%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 15 |
1 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
URINARY TRACT INFECTION ENTEROCOCCAL
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
URINARY TRACT INFECTION BACTERIAL
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
UROSEPSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
VIRAL INFECTION
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
VULVAL ABSCESS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
WOUND INFECTION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
WOUND SEPSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
WOUND INFECTION STAPHYLOCOCCAL
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
DECREASED APPETITE
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
CACHEXIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DEHYDRATION
|
|
|
|
subjects affected / exposed
|
7 / 5107 (0.14%) |
8 / 1830 (0.44%) |
11 / 1829 (0.60%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
1 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIABETES MELLITUS
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
4 / 1830 (0.22%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIABETES MELLITUS INADEQUATE CONTROL
|
|
|
|
subjects affected / exposed
|
3 / 5107 (0.06%) |
7 / 1830 (0.38%) |
9 / 1829 (0.49%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIABETIC KETOACIDOSIS
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIABETIC KETOSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
DIABETIC METABOLIC DECOMPENSATION
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
3 / 1830 (0.16%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
ELECTROLYTE IMBALANCE
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
2 / 1830 (0.11%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
FLUID OVERLOAD
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
3 / 1830 (0.16%) |
9 / 1829 (0.49%) |
occurrences causally related to treatment / all
|
1 / 2 |
2 / 3 |
3 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
FLUID RETENTION
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
0 / 1830 (0.00%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
GOUT
|
|
|
|
subjects affected / exposed
|
1 / 5107 (0.02%) |
2 / 1830 (0.11%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPERCALCAEMIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPERGLYCAEMIA
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
9 / 1830 (0.49%) |
8 / 1829 (0.44%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 11 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPERGLYCAEMIC HYPEROSMOLAR NONKETOTIC SYNDROME
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPERKALAEMIA
|
|
|
|
subjects affected / exposed
|
5 / 5107 (0.10%) |
16 / 1830 (0.87%) |
16 / 1829 (0.87%) |
occurrences causally related to treatment / all
|
1 / 6 |
3 / 19 |
2 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPERURICAEMIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPOCALCAEMIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPOALBUMINAEMIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPONATRAEMIA
|
|
|
|
subjects affected / exposed
|
2 / 5107 (0.04%) |
2 / 1830 (0.11%) |
3 / 1829 (0.16%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPOMAGNESAEMIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPOGLYCAEMIA
|
|
|
|
subjects affected / exposed
|
13 / 5107 (0.25%) |
12 / 1830 (0.66%) |
22 / 1829 (1.20%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 14 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPOVOLAEMIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
HYPOPHAGIA
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
0 / 1830 (0.00%) |
1 / 1829 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
METABOLIC ACIDOSIS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
6 / 1830 (0.33%) |
5 / 1829 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
OBESITY
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
2 / 1829 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
TYPE 2 DIABETES MELLITUS
|
|
|
|
subjects affected / exposed
|
0 / 5107 (0.00%) |
1 / 1830 (0.05%) |
0 / 1829 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |