Serious adverse events
|
Placebo |
Canagliflozin 100 mg |
Canagliflozin 300 mg |
Total subjects affected by serious adverse events
|
|
|
|
subjects affected / exposed
|
584 / 1441 (40.53%) |
601 / 1445 (41.59%) |
606 / 1441 (42.05%) |
number of deaths (all causes)
|
74 |
68 |
66 |
number of deaths resulting from adverse events
|
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
Acute Leukaemia
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Adenocarcinoma Gastric
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
4 / 1441 (0.28%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Adenocarcinoma of Colon
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
3 / 1445 (0.21%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adenolymphoma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adenosquamous Cell Lung Cancer
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Adrenal Adenoma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal Squamous Cell Carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Appendix Adenoma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Basal Cell Carcinoma
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
3 / 1445 (0.21%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign Neoplasm of Bladder
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Benign Neoplasm of Prostate
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Benign Peritoneal Neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Bladder Cancer
|
|
|
|
subjects affected / exposed
|
5 / 1441 (0.35%) |
4 / 1445 (0.28%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
2 / 5 |
1 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 0 |
Bladder Cancer Stage 0, with Cancer in Situ
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 Papilloma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder Transitional Cell Carcinoma
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast Cancer
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
3 / 1445 (0.21%) |
6 / 1441 (0.42%) |
occurrences causally related to treatment / all
|
1 / 3 |
1 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 1 |
Breast Cancer Recurrent
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast Cancer Stage I
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial Carcinoma
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
Bronchial Neoplasm Benign
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Carcinoid Tumour of the Duodenum
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Carotid Body Tumour
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chondrosarcoma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chondrosarcoma Metastatic
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Chronic Myeloid Leukaemia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 Myelomonocytic Leukaemia
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Clear Cell Renal Cell Carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colon Adenoma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colon Cancer
|
|
|
|
subjects affected / exposed
|
4 / 1441 (0.28%) |
1 / 1445 (0.07%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Colon Cancer Metastatic
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
4 / 1441 (0.28%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
Colon Cancer Stage Iii
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Colorectal Cancer
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Diffuse Large B-Cell Lymphoma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Endometrial Adenocarcinoma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial Cancer
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 Cancer
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Gallbladder Cancer Metastatic
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 Cancer
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal Tract Adenoma
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Head and Neck Cancer
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 / 1441 (0.00%) |
3 / 1445 (0.21%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
Hepatic Cancer Metastatic
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatocellular Carcinoma
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hodgkin's Disease
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Invasive Ductal Breast Carcinoma
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Kidney Angiomyolipoma
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Large Cell Lung Cancer
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Large Intestine Benign Neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Laryngeal Squamous Cell Carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Lentigo Maligna
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Lipoma
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung Adenocarcinoma
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Lung Adenocarcinoma Metastatic
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Lung Cancer Metastatic
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
Lung Neoplasm Malignant
|
|
|
|
subjects affected / exposed
|
4 / 1441 (0.28%) |
3 / 1445 (0.21%) |
4 / 1441 (0.28%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
Lung Squamous Cell Carcinoma Stage 0
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Lymphocytic Lymphoma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lymphoma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Malignant Melanoma
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Malignant Melanoma in Situ
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Melanocytic Naevus
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meningioma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to Bone
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Metastases to Central Nervous System
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Metastases to Lymph Nodes
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to Peritoneum
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Metastases to Small Intestine
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Metastatic Carcinoid Tumour
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Metastatic Carcinoma of the Bladder
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Metastatic Malignant Melanoma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Renal Cell Carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Monoclonal Gammopathy
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myelodysplastic Syndrome
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myeloid Leukaemia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Myeloproliferative Neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neuroendocrine Carcinoma Metastatic
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neuroendocrine Carcinoma of the Skin
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-Small Cell Lung Cancer
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Non-Small Cell Lung Cancer Stage Iv
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Oesophageal Adenocarcinoma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Ovarian Cancer
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Ovarian Cancer Metastatic
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Pancreatic Carcinoma
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
Pancreatic Carcinoma Metastatic
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
Pancreatic Neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Papillary Serous Endometrial Carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Papillary Thyroid Cancer
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Paraneoplastic Syndrome
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Parathyroid Tumour Benign
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Penile Cancer
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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
|
7 / 1441 (0.49%) |
8 / 1445 (0.55%) |
6 / 1441 (0.42%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 9 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostate Cancer Metastatic
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostate Cancer Recurrent
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Prostatic Adenoma
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal Adenocarcinoma
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
2 / 1445 (0.14%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Rectal Adenoma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 Cancer
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal Cancer Recurrent
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Rectosigmoid Cancer
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal Cancer
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal Cancer Metastatic
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Renal Cancer Stage I
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 Cell Carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Renal Cell Carcinoma Stage Ii
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal Oncocytoma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sarcoma Uterus
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Seminoma
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin Cancer
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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
|
2 / 1441 (0.14%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Squamous Cell Carcinoma of Skin
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Squamous Cell Carcinoma of the Oral Cavity
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Squamous Cell Carcinoma of the Tongue
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Superficial Spreading Melanoma Stage Unspecified
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Testicular Seminoma (Pure)
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Throat Cancer
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thyroid Adenoma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thyroid Cancer
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Tonsil Cancer
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transitional Cell Cancer of the Renal Pelvis and Ureter
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Transitional Cell Carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine Cancer
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Uterine Leiomyoma
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vulvovaginal Warts
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Vascular disorders
|
|
|
|
Accelerated Hypertension
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic Aneurysm
|
|
|
|
subjects affected / exposed
|
4 / 1441 (0.28%) |
2 / 1445 (0.14%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic Stenosis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
3 / 1445 (0.21%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Arterial Disorder
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arterial Occlusive Disease
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arterial Thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood Pressure Inadequately Controlled
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Circulatory Collapse
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Deep Vein Thrombosis
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
4 / 1445 (0.28%) |
5 / 1441 (0.35%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Dry Gangrene
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Extremity Necrosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
4 / 1441 (0.28%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematoma
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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
|
10 / 1441 (0.69%) |
3 / 1445 (0.21%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive Crisis
|
|
|
|
subjects affected / exposed
|
4 / 1441 (0.28%) |
5 / 1445 (0.35%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive Emergency
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypotension
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
5 / 1445 (0.35%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
1 / 3 |
1 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Iliac Artery Occlusion
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intermittent Claudication
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
3 / 1445 (0.21%) |
4 / 1441 (0.28%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemia
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Leriche Syndrome
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lymphoedema
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Malignant Hypertension
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neurogenic Shock
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Orthostatic Hypotension
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral Arterial Occlusive Disease
|
|
|
|
subjects affected / exposed
|
4 / 1441 (0.28%) |
12 / 1445 (0.83%) |
11 / 1441 (0.76%) |
occurrences causally related to treatment / all
|
0 / 4 |
2 / 19 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral Artery Aneurysm
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral Artery Occlusion
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
7 / 1445 (0.48%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral Artery Stenosis
|
|
|
|
subjects affected / exposed
|
4 / 1441 (0.28%) |
5 / 1445 (0.35%) |
7 / 1441 (0.49%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 6 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral Artery Thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral Ischaemia
|
|
|
|
subjects affected / exposed
|
9 / 1441 (0.62%) |
9 / 1445 (0.62%) |
6 / 1441 (0.42%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 10 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral Vascular Disorder
|
|
|
|
subjects affected / exposed
|
7 / 1441 (0.49%) |
8 / 1445 (0.55%) |
10 / 1441 (0.69%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 8 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Subclavian Artery Stenosis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Thrombophlebitis Superficial
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Varicose Vein
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
|
Arrhythmia Prophylaxis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Fracture Treatment
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Bypass
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Hip Arthroplasty
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incisional Hernia Repair
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
General disorders and administration site conditions
|
|
|
|
Adverse Drug Reaction
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Application Site Dermatitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Asthenia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Chest Discomfort
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
3 / 1445 (0.21%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chest Pain
|
|
|
|
subjects affected / exposed
|
23 / 1441 (1.60%) |
26 / 1445 (1.80%) |
13 / 1441 (0.90%) |
occurrences causally related to treatment / all
|
0 / 26 |
0 / 28 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Complication Associated with Device
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Death
|
|
|
|
subjects affected / exposed
|
8 / 1441 (0.56%) |
8 / 1445 (0.55%) |
8 / 1441 (0.56%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 8 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 8 |
0 / 8 |
Drug Intolerance
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 Pain
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Fatigue
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Generalised Oedema
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Impaired Healing
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Ischaemic Ulcer
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Medical Device Site Reaction
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Necrosis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Non-Cardiac Chest Pain
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
8 / 1445 (0.55%) |
5 / 1441 (0.35%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oedema Peripheral
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
3 / 1445 (0.21%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Perforated Ulcer
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Peripheral Swelling
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Pyrexia
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
3 / 1445 (0.21%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Strangulated Hernia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sudden Cardiac Death
|
|
|
|
subjects affected / exposed
|
5 / 1441 (0.35%) |
0 / 1445 (0.00%) |
9 / 1441 (0.62%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 9 |
Sudden Death
|
|
|
|
subjects affected / exposed
|
6 / 1441 (0.42%) |
5 / 1445 (0.35%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 5 |
0 / 3 |
Vascular Stent Occlusion
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Stent Restenosis
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
3 / 1445 (0.21%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
Atopy
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Drug Hypersensitivity
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Food Allergy
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Reproductive system and breast disorders
|
|
|
|
Acquired Phimosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adenomyosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign Prostatic Hyperplasia
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
8 / 1445 (0.55%) |
15 / 1441 (1.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 8 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervical Dysplasia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cystocele
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial Hyperplasia
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Epididymal Cyst
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Erectile Dysfunction
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Genital Prolapse
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Orchitis Noninfective
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian Cyst
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic Prolapse
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic Calcification
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatomegaly
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectocele
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Polyp
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine Prolapse
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterovaginal Prolapse
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Vaginal Prolapse
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
Acute Pulmonary Oedema
|
|
|
|
subjects affected / exposed
|
6 / 1441 (0.42%) |
3 / 1445 (0.21%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute Respiratory Distress Syndrome
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
3 / 1445 (0.21%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute Respiratory Failure
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Asthma
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
4 / 1445 (0.28%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial Hyperreactivity
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Obstructive Pulmonary Disease
|
|
|
|
subjects affected / exposed
|
7 / 1441 (0.49%) |
7 / 1445 (0.48%) |
7 / 1441 (0.49%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cough
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diaphragmatic Disorder
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dysphonia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
|
subjects affected / exposed
|
8 / 1441 (0.56%) |
11 / 1445 (0.76%) |
7 / 1441 (0.49%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 11 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Dyspnoea Exertional
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
4 / 1445 (0.28%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
2 / 1445 (0.14%) |
4 / 1441 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Idiopathic Pulmonary Fibrosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Interstitial Lung Disease
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Laryngeal Oedema
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung Consolidation
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung Infiltration
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nasal Polyps
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Organising Pneumonia
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Pleural Effusion
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia Aspiration
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Pneumonitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Productive Cough
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Pulmonary Embolism
|
|
|
|
subjects affected / exposed
|
7 / 1441 (0.49%) |
5 / 1445 (0.35%) |
9 / 1441 (0.62%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
Pulmonary Fibrosis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Pulmonary Hypertension
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary Oedema
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Pulmonary Vein Stenosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory Acidosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Respiratory Arrest
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Respiratory Distress
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Respiratory Failure
|
|
|
|
subjects affected / exposed
|
6 / 1441 (0.42%) |
3 / 1445 (0.21%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 1 |
Sinus Polyp
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sleep Apnoea Syndrome
|
|
|
|
subjects affected / exposed
|
4 / 1441 (0.28%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
Affective Disorder
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Alcoholism
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Anxiety
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Completed Suicide
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Confusional State
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Delirium
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Delirium Tremens
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Depression
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hallucination
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Hallucination, Visual
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Major Depression
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mental Disorder
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mental Status Changes
|
|
|
|
subjects affected / exposed
|
4 / 1441 (0.28%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Paranoia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Schizoaffective Disorder
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Schizophrenia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Suicide Attempt
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular Cognitive Impairment
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Product issues
|
|
|
|
Device Breakage
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device Damage
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
Alcoholic Liver Disease
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Bile Duct Obstruction
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 Stone
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholangitis Acute
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
5 / 1445 (0.35%) |
5 / 1441 (0.35%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis Acute
|
|
|
|
subjects affected / exposed
|
4 / 1441 (0.28%) |
6 / 1445 (0.42%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Cholecystitis Chronic
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
|
subjects affected / exposed
|
11 / 1441 (0.76%) |
9 / 1445 (0.62%) |
7 / 1441 (0.49%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 11 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholestasis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Drug-Induced Liver Injury
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Gallbladder Disorder
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gallbladder Pain
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gallbladder Perforation
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Gallbladder Polyp
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 Cirrhosis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Hepatic Failure
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Hepatic Fibrosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatomegaly
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Hepatorenal Syndrome
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Jaundice Cholestatic
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Liver Disorder
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-Alcoholic Steatohepatitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Portal Hypertension
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Portal Vein Thrombosis
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post Cholecystectomy Syndrome
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
Alanine Aminotransferase Increased
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Blood Creatinine Increased
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Blood Glucose Abnormal
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Glucose Increased
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood Pressure Abnormal
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Pressure Decreased
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Pressure Increased
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Stress Test Abnormal
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Catheterisation Cardiac
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 Test Positive
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colonoscopy
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Electrocardiogram Abnormal
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Electrocardiogram St Segment Depression
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Electrocardiogram St-T Segment Abnormal
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Exercise Test Abnormal
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gamma-Glutamyltransferase Increased
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Glomerular Filtration Rate Decreased
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Hepatic Enzyme Increased
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intraocular Pressure Increased
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Liver Function Test Increased
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Precancerous Cells Present
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Function Test Abnormal
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Troponin Increased
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Weight Decreased
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
Accident
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Accidental Overdose
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acetabulum Fracture
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Alcohol Poisoning
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anaesthetic Complication
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Animal Bite
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ankle Fracture
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
6 / 1445 (0.42%) |
5 / 1441 (0.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arterial Bypass Occlusion
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arterial Bypass Stenosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bone Contusion
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Brain Contusion
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervical Vertebral Fracture
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clavicle Fracture
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Concussion
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Contusion
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary Artery Restenosis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Craniocerebral Injury
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Dural Tear
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
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 Bones Fracture
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fall
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femoral Neck Fracture
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
4 / 1445 (0.28%) |
4 / 1441 (0.28%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femur Fracture
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
7 / 1441 (0.49%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fibula Fracture
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Foot Fracture
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Foreign Body
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Foreign Body in Eye
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fracture Displacement
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Head Injury
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Heat Stroke
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Hip Fracture
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
4 / 1445 (0.28%) |
7 / 1441 (0.49%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
2 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Humerus Fracture
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
4 / 1445 (0.28%) |
8 / 1441 (0.56%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Joint Dislocation
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Joint Injury
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Laceration
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ligament Rupture
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ligament Sprain
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Limb Injury
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower Limb Fracture
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar Vertebral Fracture
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meniscus Injury
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Multiple Injuries
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Muscle Rupture
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (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 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic Fracture
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral Artery Restenosis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post Concussion Syndrome
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 Bile Leak
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post Procedural Complication
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative Renal Failure
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Postoperative Respiratory Failure
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative Thoracic Procedure Complication
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Wound Complication
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Procedural Haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Procedural Nausea
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 Vomiting
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Pubis Fracture
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Radius Fracture
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
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 / 1441 (0.07%) |
3 / 1445 (0.21%) |
8 / 1441 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Road Traffic Accident
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
Skin Injury
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Skull Fracture
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skull Fractured Base
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal Compression Fracture
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal Cord Injury
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 Fracture
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sternal Fracture
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Stomal Hernia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 / 1441 (0.07%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subcutaneous Haematoma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subdural Haematoma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subdural Haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tendon Injury
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tendon Rupture
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Thermal Burn
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Tibia Fracture
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
4 / 1445 (0.28%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic Haematoma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 Intracranial Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Ulna Fracture
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper Limb Fracture
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary Retention Postoperative
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Vascular Graft Complication
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 Pseudoaneurysm
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Wound
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
2 / 1445 (0.14%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound Complication
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound Necrosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wrist Fracture
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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
|
|
|
|
Arteriovenous Malformation
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Developmental Hip Dysplasia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hydrocele
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Phimosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
4 / 1441 (0.28%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vitello-Intestinal Duct Remnant
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Cardiac disorders
|
|
|
|
Acute Coronary Syndrome
|
|
|
|
subjects affected / exposed
|
8 / 1441 (0.56%) |
3 / 1445 (0.21%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Acute Left Ventricular Failure
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute Myocardial Infarction
|
|
|
|
subjects affected / exposed
|
10 / 1441 (0.69%) |
10 / 1445 (0.69%) |
8 / 1441 (0.56%) |
occurrences causally related to treatment / all
|
0 / 10 |
1 / 10 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 2 |
Adams-Stokes Syndrome
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Angina Pectoris
|
|
|
|
subjects affected / exposed
|
24 / 1441 (1.67%) |
15 / 1445 (1.04%) |
30 / 1441 (2.08%) |
occurrences causally related to treatment / all
|
0 / 30 |
0 / 16 |
0 / 38 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Angina Unstable
|
|
|
|
subjects affected / exposed
|
20 / 1441 (1.39%) |
24 / 1445 (1.66%) |
28 / 1441 (1.94%) |
occurrences causally related to treatment / all
|
1 / 24 |
1 / 28 |
0 / 34 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anginal Equivalent
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Aortic Valve Incompetence
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic Valve Stenosis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
0 / 1445 (0.00%) |
4 / 1441 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Arteriosclerosis Coronary Artery
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Atrial Fibrillation
|
|
|
|
subjects affected / exposed
|
26 / 1441 (1.80%) |
22 / 1445 (1.52%) |
17 / 1441 (1.18%) |
occurrences causally related to treatment / all
|
0 / 27 |
0 / 28 |
1 / 28 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Atrial Flutter
|
|
|
|
subjects affected / exposed
|
6 / 1441 (0.42%) |
6 / 1445 (0.42%) |
8 / 1441 (0.56%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular Block
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular Block Complete
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
2 / 1445 (0.14%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular Block Second Degree
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
2 / 1445 (0.14%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
|
subjects affected / exposed
|
4 / 1441 (0.28%) |
2 / 1445 (0.14%) |
5 / 1441 (0.35%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac Arrest
|
|
|
|
subjects affected / exposed
|
6 / 1441 (0.42%) |
7 / 1445 (0.48%) |
6 / 1441 (0.42%) |
occurrences causally related to treatment / all
|
0 / 6 |
1 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 5 |
Cardiac Disorder
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac Failure
|
|
|
|
subjects affected / exposed
|
19 / 1441 (1.32%) |
19 / 1445 (1.31%) |
23 / 1441 (1.60%) |
occurrences causally related to treatment / all
|
1 / 23 |
0 / 28 |
1 / 28 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 3 |
Cardiac Failure Acute
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
Cardiac Failure Chronic
|
|
|
|
subjects affected / exposed
|
5 / 1441 (0.35%) |
3 / 1445 (0.21%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Cardiac Failure Congestive
|
|
|
|
subjects affected / exposed
|
20 / 1441 (1.39%) |
15 / 1445 (1.04%) |
14 / 1441 (0.97%) |
occurrences causally related to treatment / all
|
0 / 28 |
0 / 23 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 3 |
Cardio-Respiratory Arrest
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
3 / 1445 (0.21%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
1 / 3 |
0 / 0 |
Cardiogenic Shock
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
4 / 1441 (0.28%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
Cardiomyopathy
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiopulmonary Failure
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Cardiovascular Disorder
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Cor Pulmonale
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary Artery Disease
|
|
|
|
subjects affected / exposed
|
24 / 1441 (1.67%) |
24 / 1445 (1.66%) |
23 / 1441 (1.60%) |
occurrences causally related to treatment / all
|
0 / 25 |
0 / 28 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
Coronary Artery Insufficiency
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary Artery Occlusion
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
2 / 1445 (0.14%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary Artery Stenosis
|
|
|
|
subjects affected / exposed
|
5 / 1441 (0.35%) |
5 / 1445 (0.35%) |
7 / 1441 (0.49%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary Artery Thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Hypertensive Heart Disease
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 Cardiomyopathy
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Left Ventricular Dysfunction
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Left Ventricular Failure
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mitral Valve Incompetence
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial Fibrosis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Myocardial Infarction
|
|
|
|
subjects affected / exposed
|
16 / 1441 (1.11%) |
18 / 1445 (1.25%) |
11 / 1441 (0.76%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 18 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 11 |
0 / 7 |
Myocardial Ischaemia
|
|
|
|
subjects affected / exposed
|
9 / 1441 (0.62%) |
11 / 1445 (0.76%) |
6 / 1441 (0.42%) |
occurrences causally related to treatment / all
|
0 / 11 |
1 / 14 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Palpitations
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pericardial Effusion
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pericarditis Constrictive
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulseless Electrical Activity
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Restrictive Cardiomyopathy
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Right Ventricular Failure
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Sinus Bradycardia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinus Node Dysfunction
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Supraventricular Tachycardia
|
|
|
|
subjects affected / exposed
|
6 / 1441 (0.42%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular Arrhythmia
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Ventricular Extrasystoles
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular Fibrillation
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
Ventricular Tachycardia
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
2 / 1445 (0.14%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
|
Alcoholic Seizure
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Amyotrophic Lateral Sclerosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aphasia
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Ataxia
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Basal Ganglia Infarction
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Basilar Artery Occlusion
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Injury
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Brain Stem Infarction
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Carotid Arteriosclerosis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Carotid Artery Stenosis
|
|
|
|
subjects affected / exposed
|
5 / 1441 (0.35%) |
5 / 1445 (0.35%) |
11 / 1441 (0.76%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carotid Sinus Syndrome
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carpal Tunnel Syndrome
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
2 / 1445 (0.14%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebellar Ataxia
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Cerebellar Infarction
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Cerebral Arteriosclerosis
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Cerebral Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Cerebral Infarction
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
2 / 1445 (0.14%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular Accident
|
|
|
|
subjects affected / exposed
|
10 / 1441 (0.69%) |
13 / 1445 (0.90%) |
13 / 1441 (0.90%) |
occurrences causally related to treatment / all
|
1 / 10 |
0 / 13 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 6 |
Cervicobrachial Syndrome
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Cubital Tunnel Syndrome
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Depressed Level of Consciousness
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 Coma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Hyperosmolar Coma
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Dizziness
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Facial Paralysis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Facial Paresis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Generalised Tonic-Clonic Seizure
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Guillain-Barre Syndrome
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage Intracranial
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Haemorrhagic Stroke
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
Headache
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Hemiparesis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 Encephalopathy
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemic Coma
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Hyponatraemic Encephalopathy
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Intercostal Neuralgia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intracranial Haematoma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic Stroke
|
|
|
|
subjects affected / exposed
|
4 / 1441 (0.28%) |
3 / 1445 (0.21%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
Lacunar Infarction
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lacunar Stroke
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Loss of Consciousness
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar Radiculopathy
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lumbosacral Radiculopathy
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mental Impairment
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
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 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Motor Dysfunction
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myasthenia Gravis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neuralgia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Orthostatic Intolerance
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Paralysis Recurrent Laryngeal Nerve
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Parkinson's Disease
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Parkinsonism
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Partial Seizures
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Petit Mal Epilepsy
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post Herpetic Neuralgia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Presyncope
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
2 / 1445 (0.14%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Radiculopathy
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Reversible Cerebral Vasoconstriction Syndrome
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Seizure
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Serotonin Syndrome
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Somnolence
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 Claudication
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Cord Compression
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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
|
7 / 1441 (0.49%) |
9 / 1445 (0.62%) |
5 / 1441 (0.35%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transient Ischaemic Attack
|
|
|
|
subjects affected / exposed
|
15 / 1441 (1.04%) |
7 / 1445 (0.48%) |
16 / 1441 (1.11%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 8 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Trigeminal Neuralgia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 Encephalopathy
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vertebrobasilar Insufficiency
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Vertigo CNS Origin
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vith Nerve Paralysis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vocal Cord Paralysis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
Anaemia
|
|
|
|
subjects affected / exposed
|
8 / 1441 (0.56%) |
2 / 1445 (0.14%) |
7 / 1441 (0.49%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 2 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic Anaemia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypochromic Anaemia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Iron Deficiency Anaemia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Microcytic Anaemia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Normochromic Normocytic Anaemia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pernicious Anaemia
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Splenomegaly
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
|
Deafness Neurosensory
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoacusis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
2 / 1445 (0.14%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo Positional
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
Amaurosis Fugax
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blindness Unilateral
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Cataract
|
|
|
|
subjects affected / exposed
|
8 / 1441 (0.56%) |
8 / 1445 (0.55%) |
10 / 1441 (0.69%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 10 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cataract Diabetic
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cataract Nuclear
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Cataract Subcapsular
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Dacryostenosis Acquired
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 Retinopathy
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
3 / 1445 (0.21%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diplopia
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Exophthalmos
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Eye Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
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 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Glaucoma
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
0 / 1445 (0.00%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lens Dislocation
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Macular Degeneration
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Macular Fibrosis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Macular Hole
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Maculopathy
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ocular Myasthenia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Open Angle Glaucoma
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Optic Ischaemic Neuropathy
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Retinal Detachment
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Retinal Vascular Thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinopathy Proliferative
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ulcerative Keratitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Visual Impairment
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 Floaters
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vitreous Haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
Abdominal Hernia
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
2 / 1445 (0.14%) |
5 / 1441 (0.35%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal Incarcerated Hernia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal Pain
|
|
|
|
subjects affected / exposed
|
4 / 1441 (0.28%) |
3 / 1445 (0.21%) |
5 / 1441 (0.35%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal Pain Upper
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (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 Wall Haematoma
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 Fissure
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal Fistula
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 / 1441 (0.07%) |
1 / 1445 (0.07%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bowel Movement Irregularity
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Gastritis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Colitis Ischaemic
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Colitis Microscopic
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Colitis Ulcerative
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Colon Dysplasia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colonic Pseudo-Obstruction
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Constipation
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
2 / 1445 (0.14%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
3 / 1445 (0.21%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dieulafoy's Vascular Malformation
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum Intestinal
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Diverticulum Intestinal Haemorrhagic
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal Ulcer
|
|
|
|
subjects affected / exposed
|
4 / 1441 (0.28%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Erosive Duodenitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eructation
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Food Poisoning
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gallstone Ileus
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric Mucosal Hypertrophy
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Perforation
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Gastric Ulcer
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric Ulcer Perforation
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Gastritis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
2 / 1445 (0.14%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal Erosion
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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
|
2 / 1441 (0.14%) |
0 / 1445 (0.00%) |
4 / 1441 (0.28%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal Necrosis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal Obstruction
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 / 1441 (0.07%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoidal Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Haemorrhoids
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
3 / 1445 (0.21%) |
0 / 1441 (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 |
Hernial Eventration
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hiatus Hernia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ileus
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
3 / 1445 (0.21%) |
0 / 1441 (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 |
Ileus Paralytic
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated Umbilical Hernia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal Hernia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
3 / 1445 (0.21%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal Haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal Ischaemia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal Polyp
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Intra-Abdominal Haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intussusception
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Large Intestine Perforation
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Large Intestine Polyp
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Lower Gastrointestinal Haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mallory-Weiss Syndrome
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 Achalasia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal Obstruction
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal Ulcer
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal Varices Haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Cyst
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Pancreatic Pseudocyst
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Pancreatitis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
3 / 1445 (0.21%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis Acute
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
4 / 1445 (0.28%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis Haemorrhagic
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Pancreatitis Necrotising
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Rectal Haemorrhage
|
|
|
|
subjects affected / exposed
|
4 / 1441 (0.28%) |
6 / 1445 (0.42%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 7 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal Ulcer
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Small Intestinal Obstruction
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tooth Disorder
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Umbilical Hernia
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper Gastrointestinal Haemorrhage
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
3 / 1445 (0.21%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Varices Oesophageal
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vomiting
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
Angioedema
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Decubitus Ulcer
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Dermatitis Contact
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Foot
|
|
|
|
subjects affected / exposed
|
4 / 1441 (0.28%) |
9 / 1445 (0.62%) |
10 / 1441 (0.69%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 10 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic Neuropathic Ulcer
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 Ulcer
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 Eruption
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Eczema
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Guttate Psoriasis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Hyperhidrosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypersensitivity Vasculitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Keloid Scar
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Lichen Planus
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Necrobiosis Lipoidica Diabeticorum
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Neurodermatitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rash
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin Disorder
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Lesion
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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
|
2 / 1441 (0.14%) |
10 / 1445 (0.69%) |
14 / 1441 (0.97%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 11 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urticaria
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
Acute Kidney Injury
|
|
|
|
subjects affected / exposed
|
13 / 1441 (0.90%) |
15 / 1445 (1.04%) |
8 / 1441 (0.56%) |
occurrences causally related to treatment / all
|
1 / 14 |
0 / 16 |
2 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
Azotaemia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Bladder Neck Obstruction
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 Prolapse
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
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 Stenosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Bladder
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Calculus Urinary
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Kidney Disease
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis Haemorrhagic
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Nephropathy
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dysuria
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematuria
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
2 / 1445 (0.14%) |
4 / 1441 (0.28%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
2 / 1445 (0.14%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
|
subjects affected / exposed
|
7 / 1441 (0.49%) |
2 / 1445 (0.14%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oliguria
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Renal Artery Stenosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 Colic
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal Failure
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
2 / 1445 (0.14%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal Impairment
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
6 / 1445 (0.42%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
1 / 1 |
5 / 7 |
3 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal Papillary Necrosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal Tubular Necrosis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Stress Urinary Incontinence
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Terminal Dribbling
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tubulointerstitial Nephritis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ureteric Obstruction
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ureterolithiasis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urethral Meatus Stenosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urethral Stenosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
4 / 1441 (0.28%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary Bladder Polyp
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 Incontinence
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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
|
2 / 1441 (0.14%) |
0 / 1445 (0.00%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary Tract Obstruction
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
|
Empty Sella Syndrome
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Goitre
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperparathyroidism
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperparathyroidism Primary
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Inappropriate Antidiuretic Hormone Secretion
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thyroiditis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
Acquired Claw Toe
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ankylosing Spondylitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthralgia
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
5 / 1445 (0.35%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
3 / 1445 (0.21%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthropathy
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Back Pain
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
5 / 1445 (0.35%) |
4 / 1441 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bone Atrophy
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Bone Cyst
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Bursitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chondromalacia
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Chondropathy
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Costochondritis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Arthropathy
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Dupuytren's Contracture
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Exostosis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Flank Pain
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Foot Deformity
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gouty Arthritis
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Gouty Tophus
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Haemarthrosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Compression
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral Disc Degeneration
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Intervertebral Disc Disorder
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Intervertebral Disc Protrusion
|
|
|
|
subjects affected / exposed
|
4 / 1441 (0.28%) |
3 / 1445 (0.21%) |
6 / 1441 (0.42%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Juvenile Idiopathic Arthritis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Lumbar Spinal Stenosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
8 / 1445 (0.55%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 10 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lupus-Like Syndrome
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Muscle Atrophy
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal Chest Pain
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal Pain
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myalgia
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Neck Pain
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neuropathic Arthropathy
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
|
subjects affected / exposed
|
27 / 1441 (1.87%) |
30 / 1445 (2.08%) |
23 / 1441 (1.60%) |
occurrences causally related to treatment / all
|
0 / 30 |
0 / 39 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteochondrosis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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
|
4 / 1441 (0.28%) |
3 / 1445 (0.21%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Periarthritis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
3 / 1445 (0.21%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Polyarthritis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Polymyalgia Rheumatica
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Psoriatic Arthropathy
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rotator Cuff Syndrome
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
2 / 1445 (0.14%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Senile Osteoporosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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
|
6 / 1441 (0.42%) |
4 / 1445 (0.28%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal Osteoarthritis
|
|
|
|
subjects affected / exposed
|
4 / 1441 (0.28%) |
3 / 1445 (0.21%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal Pain
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spondyloarthropathy
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
2 / 1445 (0.14%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Synovial Cyst
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tendon Disorder
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tendonitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tenosynovitis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Vertebral Foraminal Stenosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
Abdominal Abscess
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Abdominal Sepsis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Abscess
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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
|
4 / 1441 (0.28%) |
5 / 1445 (0.35%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal Abscess
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
2 / 1445 (0.14%) |
0 / 1441 (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 |
Appendicitis
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
3 / 1445 (0.21%) |
6 / 1441 (0.42%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis Perforated
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Arthritis Bacterial
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Arthritis Infective
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atypical Pneumonia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Bacterial Sepsis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Biliary Sepsis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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
|
4 / 1441 (0.28%) |
5 / 1445 (0.35%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis Bacterial
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Bronchopulmonary Aspergillosis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Burn Infection
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Campylobacter Gastroenteritis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carbuncle
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
subjects affected / exposed
|
19 / 1441 (1.32%) |
15 / 1445 (1.04%) |
15 / 1441 (1.04%) |
occurrences causally related to treatment / all
|
1 / 19 |
0 / 25 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Cellulitis Gangrenous
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis Staphylococcal
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis Infective
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic Hepatitis B
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic Sinusitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium Difficile Colitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 Gangrene
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device Related Infection
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic Foot Infection
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
2 / 1445 (0.14%) |
6 / 1441 (0.42%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic Gangrene
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
3 / 1445 (0.21%) |
5 / 1441 (0.35%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Enterococcal Bacteraemia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Epiglottitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
3 / 1445 (0.21%) |
5 / 1441 (0.35%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia Urinary Tract Infection
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eye Infection
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Eye Infection Fungal
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gangrene
|
|
|
|
subjects affected / exposed
|
4 / 1441 (0.28%) |
15 / 1445 (1.04%) |
6 / 1441 (0.42%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 17 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
|
subjects affected / exposed
|
6 / 1441 (0.42%) |
5 / 1445 (0.35%) |
8 / 1441 (0.56%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis Viral
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal Infection
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Groin Abscess
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Groin Infection
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematoma Infection
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Helicobacter Infection
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis C
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 E
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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
|
1 / 1441 (0.07%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hiv Infection
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Infected Cyst
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infected Dermal Cyst
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infected Skin Ulcer
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
2 / 1445 (0.14%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infective Exacerbation of Bronchiectasis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Influenza
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
3 / 1445 (0.21%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Intervertebral Discitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Klebsiella Infection
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Laryngitis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Leptospirosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Liver Abscess
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Localised Infection
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
4 / 1445 (0.28%) |
10 / 1441 (0.69%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
1 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower Respiratory Tract Infection
|
|
|
|
subjects affected / exposed
|
7 / 1441 (0.49%) |
1 / 1445 (0.07%) |
4 / 1441 (0.28%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Lung Infection
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lymphangitis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Malaria
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Medical Device Site Infection
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meningitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meningitis Viral
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Necrotising Fasciitis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nosocomial Infection
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal Candidiasis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oral Candidiasis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Orchitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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
|
7 / 1441 (0.49%) |
11 / 1445 (0.76%) |
12 / 1441 (0.83%) |
occurrences causally related to treatment / all
|
1 / 11 |
0 / 15 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis Chronic
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Otitis Externa
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Otitis Media
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Paronychia
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Pathogen Resistance
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic Abscess
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Penile Infection
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Perineal Abscess
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Perinephric Abscess
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Peritonsillar Abscess
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pharyngitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Plasmodium Vivax Infection
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
|
subjects affected / exposed
|
36 / 1441 (2.50%) |
31 / 1445 (2.15%) |
26 / 1441 (1.80%) |
occurrences causally related to treatment / all
|
1 / 41 |
0 / 35 |
0 / 27 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 2 |
Pneumonia Bacterial
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Influenzal
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post Procedural Cellulitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post Procedural Infection
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
2 / 1445 (0.14%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative Abscess
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
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 Wound Infection
|
|
|
|
subjects affected / exposed
|
5 / 1441 (0.35%) |
2 / 1445 (0.14%) |
4 / 1441 (0.28%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pseudomonal Bacteraemia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Psoas Abscess
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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 Sepsis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Pulmonary Tuberculosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
3 / 1445 (0.21%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
2 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis Acute
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis Chronic
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyoderma
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal Tuberculosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Respiratory Tract Infection
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
2 / 1445 (0.14%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory Tract Infection Viral
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Sepsis
|
|
|
|
subjects affected / exposed
|
10 / 1441 (0.69%) |
12 / 1445 (0.83%) |
4 / 1441 (0.28%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 12 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 3 |
Septic Shock
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Sialoadenitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinusitis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Soft Tissue Infection
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal Abscess
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
2 / 1441 (0.14%) |
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 Infection
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal Osteomyelitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal Sepsis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
2 / 1445 (0.14%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Streptococcal Bacteraemia
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Streptococcal Infection
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Streptococcal Sepsis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Subcutaneous Abscess
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Superinfection Bacterial
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Testicular Abscess
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tooth Infection
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Tracheobronchitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Typhoid Fever
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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
|
2 / 1441 (0.14%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary Tract Infection
|
|
|
|
subjects affected / exposed
|
16 / 1441 (1.11%) |
15 / 1445 (1.04%) |
6 / 1441 (0.42%) |
occurrences causally related to treatment / all
|
9 / 16 |
9 / 15 |
3 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
|
subjects affected / exposed
|
4 / 1441 (0.28%) |
7 / 1445 (0.48%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
3 / 4 |
1 / 8 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Vestibular Neuronitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Viral Infection
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
3 / 1445 (0.21%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Viral Pharyngitis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Viral Upper Respiratory Tract Infection
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vulval Abscess
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Wound Abscess
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
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
|
2 / 1441 (0.14%) |
0 / 1445 (0.00%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
Acidosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Decreased Appetite
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dehydration
|
|
|
|
subjects affected / exposed
|
4 / 1441 (0.28%) |
1 / 1445 (0.07%) |
4 / 1441 (0.28%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetes Mellitus
|
|
|
|
subjects affected / exposed
|
10 / 1441 (0.69%) |
6 / 1445 (0.42%) |
6 / 1441 (0.42%) |
occurrences causally related to treatment / all
|
0 / 13 |
1 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetes Mellitus Inadequate Control
|
|
|
|
subjects affected / exposed
|
7 / 1441 (0.49%) |
3 / 1445 (0.21%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic Ketoacidosis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
4 / 1445 (0.28%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
3 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fluid Overload
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gout
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
4 / 1441 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Hyperglycaemia
|
|
|
|
subjects affected / exposed
|
6 / 1441 (0.42%) |
1 / 1445 (0.07%) |
6 / 1441 (0.42%) |
occurrences causally related to treatment / all
|
2 / 6 |
0 / 1 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
3 / 1445 (0.21%) |
3 / 1441 (0.21%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 3 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Hyperosmolar Hyperglycaemic State
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
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
|
8 / 1441 (0.56%) |
12 / 1445 (0.83%) |
12 / 1441 (0.83%) |
occurrences causally related to treatment / all
|
4 / 10 |
3 / 12 |
4 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Hypokalaemia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
3 / 1445 (0.21%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoproteinaemia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ketoacidosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ketosis
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
0 / 1441 (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 |
Lactic Acidosis
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Metabolic Acidosis
|
|
|
|
subjects affected / exposed
|
2 / 1441 (0.14%) |
1 / 1445 (0.07%) |
2 / 1441 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Metabolic Disorder
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Metabolic Syndrome
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |
Obesity
|
|
|
|
subjects affected / exposed
|
3 / 1441 (0.21%) |
5 / 1445 (0.35%) |
0 / 1441 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Type 2 Diabetes Mellitus
|
|
|
|
subjects affected / exposed
|
0 / 1441 (0.00%) |
1 / 1445 (0.07%) |
1 / 1441 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vitamin B12 Deficiency
|
|
|
|
subjects affected / exposed
|
1 / 1441 (0.07%) |
0 / 1445 (0.00%) |
0 / 1441 (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 |