Serious adverse events
|
C. Difficile Vaccine Group |
Placebo Group |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
1662 / 6113 (27.19%) |
851 / 3057 (27.84%) |
number of deaths (all causes)
|
255 |
127 |
number of deaths resulting from adverse events
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Abdominal Neoplasm
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma Gastric
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Adenocarcinoma Of Colon
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma Pancreas
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Adrenal Adenoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal Cell Carcinoma
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign Bone Neoplasm
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder Cancer
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder Neoplasm
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder Transitional Cell Carcinoma Recurrent
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder Transitional Cell Carcinoma Stage Ii
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone Cancer
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain Cancer Metastatic
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Brain Neoplasm
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Brain Neoplasm Malignant
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Breast Cancer
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Breast Cancer Metastatic
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Breast Cancer Stage Ii
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast Neoplasm
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchial Carcinoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Burkitt's Lymphoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Carcinoid Tumour Of The Duodenum
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervix Carcinoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cervix Carcinoma Recurrent
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervix Carcinoma Stage I
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic Lymphocytic Leukaemia
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clear Cell Renal Cell Carcinoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon Adenoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon Cancer
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon Neoplasm
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diffuse Large B-Cell Lymphoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial Adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial Cancer
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eyelid Tumour
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder Adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric Adenoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric Neoplasm
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal Carcinoma
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal Neoplasm
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gastrointestinal Stromal Tumour
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glioblastoma Multiforme
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatic Cancer
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hepatocellular Carcinoma
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Intraductal Papillary Mucinous Neoplasm
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kaposi's Sarcoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leiomyosarcoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukaemia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lipoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung Adenocarcinoma
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung Cancer Metastatic
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lung Carcinoma Cell Type Unspecified Recurrent
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung Carcinoma Cell Type Unspecified Stage Iv
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung Neoplasm
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung Neoplasm Malignant
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Lymphoma
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant Melanoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant Neoplasm Of Eye
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant Neoplasm Of Renal Pelvis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant Pleural Effusion
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant Respiratory Tract Neoplasm
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Mantle Cell Lymphoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mediastinum Neoplasm
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningioma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesothelioma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases To Central Nervous System
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases To Lung
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic Carcinoma Of The Bladder
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Metastatic Neoplasm
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Neoplasm Malignant
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Neoplasm Of Thymus
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm Prostate
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroendocrine Tumour
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nodal Marginal Zone B-Cell Lymphoma
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-Small Cell Lung Cancer
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Non-Small Cell Lung Cancer Recurrent
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal Carcinoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ovarian Cancer
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Ovarian Epithelial Cancer
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pancreatic Carcinoma
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Pancreatic Carcinoma Metastatic
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pancreatic Neuroendocrine Tumour
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papillary Thyroid Cancer
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parathyroid Tumour Benign
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasma Cell Myeloma
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate Cancer
|
|
|
subjects affected / exposed
|
17 / 6113 (0.28%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Prostate Cancer Metastatic
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Rectal Adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal Cancer
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal Cell Carcinoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Renal Neoplasm
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal Cancer
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary Gland Adenoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary Gland Cancer
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small Cell Lung Cancer
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Small Intestine Carcinoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Squamous Cell Carcinoma
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Superficial Spreading Melanoma Stage Unspecified
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Testicular Neoplasm
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transitional Cell Carcinoma
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine Cancer
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Aneurysm
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aneurysm Ruptured
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Aortic Aneurysm
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic Aneurysm Rupture
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Aortic Stenosis
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic Thrombosis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial Occlusive Disease
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial Stenosis
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Circulatory Collapse
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deep Vein Thrombosis
|
|
|
subjects affected / exposed
|
12 / 6113 (0.20%) |
5 / 3057 (0.16%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Essential Hypertension
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extremity Necrosis
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral Artery Occlusion
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertension
|
|
|
subjects affected / exposed
|
7 / 6113 (0.11%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypertensive Crisis
|
|
|
subjects affected / exposed
|
9 / 6113 (0.15%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypertensive Emergency
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotension
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
5 / 3057 (0.16%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemic Shock
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
4 / 3057 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Infarction
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intra-Abdominal Haematoma
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphoedema
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic Hypotension
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral Arterial Occlusive Disease
|
|
|
subjects affected / exposed
|
7 / 6113 (0.11%) |
4 / 3057 (0.13%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Peripheral Artery Aneurysm
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral Artery Stenosis
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral Artery Thrombosis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral Embolism
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral Ischaemia
|
|
|
subjects affected / exposed
|
11 / 6113 (0.18%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral Vascular Disorder
|
|
|
subjects affected / exposed
|
12 / 6113 (0.20%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phlebitis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phlebitis Deep
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post Thrombotic Syndrome
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shock
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Shock Haemorrhagic
|
|
|
subjects affected / exposed
|
5 / 6113 (0.08%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Subclavian Artery Stenosis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Temporal Arteritis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thromboangiitis Obliterans
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis Superficial
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicophlebitis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose Ulceration
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular Insufficiency
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous Thrombosis
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous Thrombosis Limb
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
Artificial Urinary Sphincter Implant
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac Pacemaker Battery Replacement
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardioversion
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrospinal Fluid Drainage
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip Arthroplasty
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incisional Drainage
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Knee Arthroplasty
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Knee Operation
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leg Amputation
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metatarsal Excision
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parathyroidectomy
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rehabilitation Therapy
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth Extraction
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
Asthenia
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter Site Haemorrhage
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest Discomfort
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest Pain
|
|
|
subjects affected / exposed
|
50 / 6113 (0.82%) |
19 / 3057 (0.62%) |
occurrences causally related to treatment / all
|
0 / 56 |
0 / 27 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Death
|
|
|
subjects affected / exposed
|
8 / 6113 (0.13%) |
6 / 3057 (0.20%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 6 |
Device Dislocation
|
|
|
subjects affected / exposed
|
9 / 6113 (0.15%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device Failure
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device Issue
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device Leakage
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Device Malfunction
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device Occlusion
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug Interaction
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fatigue
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General Physical Health Deterioration
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
General Symptom
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised Oedema
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hernia Obstructive
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperthermia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired Healing
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implant Site Haematoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inflammation
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malaise
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical Device Complication
|
|
|
subjects affected / exposed
|
7 / 6113 (0.11%) |
4 / 3057 (0.13%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multi-Organ Failure
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 1 |
Non-Cardiac Chest Pain
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema Peripheral
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Patient-Device Incompatibility
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perforated Ulcer
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyp
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
subjects affected / exposed
|
5 / 6113 (0.08%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal Pain
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stent-Graft Endoleak
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden Cardiac Death
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Sudden Death
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Surgical Failure
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic Inflammatory Response Syndrome
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
Anaphylactic Reaction
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaphylactic Shock
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device Allergy
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Food Allergy
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Secondary Immunodeficiency
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Benign Prostatic Hyperplasia
|
|
|
subjects affected / exposed
|
8 / 6113 (0.13%) |
5 / 3057 (0.16%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast Enlargement
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epididymitis
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Female Genital Tract Fistula
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Genital Prolapse
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian Cyst
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postmenopausal Haemorrhage
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatomegaly
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine Haemorrhage
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal Haemorrhage
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal Prolapse
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Acute Pulmonary Oedema
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute Respiratory Distress Syndrome
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Acute Respiratory Failure
|
|
|
subjects affected / exposed
|
23 / 6113 (0.38%) |
10 / 3057 (0.33%) |
occurrences causally related to treatment / all
|
0 / 29 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 3 |
Alveolitis Allergic
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Apnoea
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aspiration
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthma
|
|
|
subjects affected / exposed
|
18 / 6113 (0.29%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atelectasis
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis Chronic
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic Obstructive Pulmonary Disease
|
|
|
subjects affected / exposed
|
84 / 6113 (1.37%) |
51 / 3057 (1.67%) |
occurrences causally related to treatment / all
|
0 / 121 |
0 / 71 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 3 |
Chronic Respiratory Failure
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Dyspnoea
|
|
|
subjects affected / exposed
|
12 / 6113 (0.20%) |
15 / 3057 (0.49%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Dyspnoea Exertional
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Emphysema
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydropneumothorax
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Idiopathic Pulmonary Fibrosis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Interstitial Lung Disease
|
|
|
subjects affected / exposed
|
6 / 6113 (0.10%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Lung Disorder
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lung Hernia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mediastinal Disorder
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mediastinal Haemorrhage
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive Airways Disorder
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural Effusion
|
|
|
subjects affected / exposed
|
21 / 6113 (0.34%) |
10 / 3057 (0.33%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pleuritic Pain
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia Aspiration
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pneumonitis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
subjects affected / exposed
|
5 / 6113 (0.08%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary Congestion
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary Embolism
|
|
|
subjects affected / exposed
|
23 / 6113 (0.38%) |
17 / 3057 (0.56%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 2 |
Pulmonary Fibrosis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary Hypertension
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary Microemboli
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary Oedema
|
|
|
subjects affected / exposed
|
6 / 6113 (0.10%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Respiratory Acidosis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Respiratory Arrest
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Respiratory Disorder
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory Distress
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Respiratory Failure
|
|
|
subjects affected / exposed
|
16 / 6113 (0.26%) |
12 / 3057 (0.39%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 6 |
Sinus Polyp
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sleep Apnoea Syndrome
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Status Asthmaticus
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheal Stenosis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Alcohol Abuse
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol Withdrawal Syndrome
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Completed Suicide
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Conversion Disorder
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delirium
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
4 / 3057 (0.13%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug Dependence
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired Self-Care
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Major Depression
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental Disorder
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental Status Changes
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
5 / 3057 (0.16%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Panic Attack
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychotic Disorder
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Schizoaffective Disorder
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Schizophrenia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicidal Ideation
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicide Attempt
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Anticoagulation Drug Level Above Therapeutic
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aspiration Bronchial
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood Creatinine Increased
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood Potassium Decreased
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carbon Dioxide Abnormal
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac Pacemaker Evaluation
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coagulation Time Prolonged
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram St Segment Elevation
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza A Virus Test Positive
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
International Normalised Ratio Increased
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oxygen Saturation Decreased
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prothrombin Time Abnormal
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transaminases Increased
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urine Output Decreased
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
Abdominal Wound Dehiscence
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Accidental Overdose
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol Poisoning
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia Postoperative
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Animal Bite
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ankle Fracture
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
4 / 3057 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial Injury
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder Injury
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone Fissure
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac Procedure Complication
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical Vertebral Fracture
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chemical Poisoning
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Concussion
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Contusion
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary Artery Restenosis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Craniocerebral Injury
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dislocation Of Vertebra
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dural Tear
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Exposure To Toxic Agent
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extradural Haematoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial Bones Fracture
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
subjects affected / exposed
|
17 / 6113 (0.28%) |
7 / 3057 (0.23%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fat Embolism
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Femur Fracture
|
|
|
subjects affected / exposed
|
11 / 6113 (0.18%) |
4 / 3057 (0.13%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral Neck Fracture
|
|
|
subjects affected / exposed
|
5 / 6113 (0.08%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot Fracture
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Forearm Fracture
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head Injury
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heat Exhaustion
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heat Stroke
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip Fracture
|
|
|
subjects affected / exposed
|
8 / 6113 (0.13%) |
6 / 3057 (0.20%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Humerus Fracture
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incisional Hernia
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint Dislocation
|
|
|
subjects affected / exposed
|
12 / 6113 (0.20%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint Dislocation Postoperative
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint Injury
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laceration
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament Injury
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament Rupture
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament Sprain
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb Injury
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower Limb Fracture
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mechanical Ventilation Complication
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Meniscus Injury
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
5 / 3057 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple Fractures
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple Injuries
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Muscle Rupture
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle Strain
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Overdose
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Patella Fracture
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic Fracture
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periprosthetic Fracture
|
|
|
subjects affected / exposed
|
6 / 6113 (0.10%) |
5 / 3057 (0.16%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax Traumatic
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post Concussion Syndrome
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post Procedural Complication
|
|
|
subjects affected / exposed
|
18 / 6113 (0.29%) |
11 / 3057 (0.36%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Post Procedural Discharge
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post Procedural Haematoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post Procedural Haematuria
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post Procedural Haemorrhage
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post Procedural Swelling
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative Fever
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative Ileus
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative Respiratory Failure
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative Thoracic Procedure Complication
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Postoperative Wound Complication
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural Haemorrhage
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural Hypotension
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural Nausea
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural Pain
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pubis Fracture
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radius Fracture
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal Laceration Postoperative
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal Haematoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rib Fracture
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Road Traffic Accident
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
5 / 3057 (0.16%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Scrotal Haematoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seroma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin Injury
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal Compression Fracture
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal Fracture
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stab Wound
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Stress Fracture
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural Haematoma
|
|
|
subjects affected / exposed
|
6 / 6113 (0.10%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Subdural Haemorrhage
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon Rupture
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thermal Burn
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thoracic Vertebral Fracture
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tibia Fracture
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxicity To Various Agents
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheostomy Malfunction
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic Arthritis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic Intracranial Haemorrhage
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper Limb Fracture
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral Injury
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral Stricture Postoperative
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular Bypass Dysfunction
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular Graft Occlusion
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular Graft Thrombosis
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular Pseudoaneurysm
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound Dehiscence
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrist Fracture
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
Anophthalmos
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac Septal Defect
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ectopic Ureter
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocele
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Acute Coronary Syndrome
|
|
|
subjects affected / exposed
|
13 / 6113 (0.21%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Acute Myocardial Infarction
|
|
|
subjects affected / exposed
|
56 / 6113 (0.92%) |
22 / 3057 (0.72%) |
occurrences causally related to treatment / all
|
0 / 59 |
1 / 24 |
deaths causally related to treatment / all
|
0 / 28 |
0 / 9 |
Angina Pectoris
|
|
|
subjects affected / exposed
|
19 / 6113 (0.31%) |
10 / 3057 (0.33%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina Unstable
|
|
|
subjects affected / exposed
|
27 / 6113 (0.44%) |
9 / 3057 (0.29%) |
occurrences causally related to treatment / all
|
0 / 32 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic Valve Incompetence
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic Valve Stenosis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
subjects affected / exposed
|
9 / 6113 (0.15%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia Supraventricular
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis Coronary Artery
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial Fibrillation
|
|
|
subjects affected / exposed
|
42 / 6113 (0.69%) |
14 / 3057 (0.46%) |
occurrences causally related to treatment / all
|
0 / 53 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial Flutter
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial Tachycardia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial Thrombosis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular Block
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular Block Complete
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradyarrhythmia
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
5 / 6113 (0.08%) |
5 / 3057 (0.16%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bundle Branch Block Left
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac Arrest
|
|
|
subjects affected / exposed
|
10 / 6113 (0.16%) |
8 / 3057 (0.26%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 4 |
Cardiac Disorder
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiac Failure
|
|
|
subjects affected / exposed
|
34 / 6113 (0.56%) |
16 / 3057 (0.52%) |
occurrences causally related to treatment / all
|
0 / 40 |
0 / 36 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
Cardiac Failure Acute
|
|
|
subjects affected / exposed
|
16 / 6113 (0.26%) |
6 / 3057 (0.20%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiac Failure Chronic
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac Failure Congestive
|
|
|
subjects affected / exposed
|
69 / 6113 (1.13%) |
29 / 3057 (0.95%) |
occurrences causally related to treatment / all
|
1 / 102 |
0 / 37 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 3 |
Cardiac Tamponade
|
|
|
subjects affected / exposed
|
6 / 6113 (0.10%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac Valve Disease
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardio-Respiratory Arrest
|
|
|
subjects affected / exposed
|
10 / 6113 (0.16%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 2 |
Cardiogenic Shock
|
|
|
subjects affected / exposed
|
8 / 6113 (0.13%) |
5 / 3057 (0.16%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 2 |
Cardiomyopathy
|
|
|
subjects affected / exposed
|
5 / 6113 (0.08%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
1 / 2 |
0 / 0 |
Cardiopulmonary Failure
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiorenal Syndrome
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cor Pulmonale
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary Artery Disease
|
|
|
subjects affected / exposed
|
22 / 6113 (0.36%) |
7 / 3057 (0.23%) |
occurrences causally related to treatment / all
|
0 / 23 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Coronary Artery Occlusion
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary Artery Stenosis
|
|
|
subjects affected / exposed
|
7 / 6113 (0.11%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary Artery Thrombosis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart Valve Incompetence
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive Heart Disease
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracardiac Thrombus
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic Cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left Ventricular Failure
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral Valve Incompetence
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial Infarction
|
|
|
subjects affected / exposed
|
27 / 6113 (0.44%) |
16 / 3057 (0.52%) |
occurrences causally related to treatment / all
|
0 / 27 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 19 |
0 / 6 |
Myocardial Ischaemia
|
|
|
subjects affected / exposed
|
8 / 6113 (0.13%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
1 / 2 |
0 / 0 |
Palpitations
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial Effusion
|
|
|
subjects affected / exposed
|
5 / 6113 (0.08%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prinzmetal Angina
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulseless Electrical Activity
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reperfusion Arrhythmia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Right Ventricular Failure
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sick Sinus Syndrome
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinoatrial Block
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus Bradycardia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress Cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular Tachyarrhythmia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular Tachycardia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachyarrhythmia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tricuspid Valve Incompetence
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricle Rupture
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular Arrhythmia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular Fibrillation
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ventricular Tachycardia
|
|
|
subjects affected / exposed
|
5 / 6113 (0.08%) |
4 / 3057 (0.13%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
Altered State Of Consciousness
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Apallic Syndrome
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arachnoid Cyst
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ataxia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain Stem Stroke
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid Arteriosclerosis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid Artery Stenosis
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carpal Tunnel Syndrome
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral Artery Stenosis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral Haemorrhage
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cerebral Infarction
|
|
|
subjects affected / exposed
|
5 / 6113 (0.08%) |
7 / 3057 (0.23%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Cerebral Ischaemia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral Thrombosis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular Accident
|
|
|
subjects affected / exposed
|
19 / 6113 (0.31%) |
8 / 3057 (0.26%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 2 |
Cerebrovascular Disorder
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cervical Myelopathy
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervicobrachial Syndrome
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Convulsion
|
|
|
subjects affected / exposed
|
11 / 6113 (0.18%) |
9 / 3057 (0.29%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Critical Illness Polyneuropathy
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia Alzheimer's Type
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia With Lewy Bodies
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic Neuropathy
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
4 / 3057 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness Postural
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolic Stroke
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
subjects affected / exposed
|
5 / 6113 (0.08%) |
4 / 3057 (0.13%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial Paresis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage Intracranial
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Haemorrhagic Stroke
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Headache
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiplegic Migraine
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic Encephalopathy
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
4 / 3057 (0.13%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Hydrocephalus
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive Encephalopathy
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoaesthesia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic Encephalopathy
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxic-Ischaemic Encephalopathy
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Intercostal Neuralgia
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracranial Aneurysm
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracranial Pressure Increased
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic Cerebral Infarction
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic Stroke
|
|
|
subjects affected / exposed
|
11 / 6113 (0.18%) |
5 / 3057 (0.16%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Lacunar Infarction
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar Radiculopathy
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic Encephalopathy
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Migraine
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathy Peripheral
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normal Pressure Hydrocephalus
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraesthesia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Partial Seizures
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumocephalus
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Polyneuropathy
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post-Traumatic Headache
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Presyncope
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radicular Pain
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radicular Syndrome
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal Cord Compression
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Status Epilepticus
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subarachnoid Haemorrhage
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Syncope
|
|
|
subjects affected / exposed
|
14 / 6113 (0.23%) |
9 / 3057 (0.29%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tension Headache
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thalamus Haemorrhage
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic Encephalopathy
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient Global Amnesia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient Ischaemic Attack
|
|
|
subjects affected / exposed
|
21 / 6113 (0.34%) |
8 / 3057 (0.26%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tremor
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Trigeminal Neuralgia
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebrobasilar Insufficiency
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo Cns Origin
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vocal Cord Paralysis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
subjects affected / exposed
|
19 / 6113 (0.31%) |
11 / 3057 (0.36%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Antiphospholipid Syndrome
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coagulopathy
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Haemolytic Anaemia
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic Anaemia
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
5 / 3057 (0.16%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Iron Deficiency Anaemia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Microcytic Anaemia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrogenic Anaemia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normochromic Normocytic Anaemia
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytosis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
Deafness Neurosensory
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniere's Disease
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden Hearing Loss
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo Positional
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Amaurosis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Amaurosis Fugax
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aphakia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Conjunctivochalasis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eyelid Ptosis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glaucoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phacolytic Glaucoma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pterygium
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal Detachment
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal Vein Occlusion
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous Haemorrhage
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Abdominal Adhesions
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Abdominal Hernia
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal Pain
|
|
|
subjects affected / exposed
|
14 / 6113 (0.23%) |
11 / 3057 (0.36%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal Pain Lower
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal Pain Upper
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal Wall Haematoma
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal Fissure
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal Fistula
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ascites
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Change Of Bowel Habit
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Colitis
|
|
|
subjects affected / exposed
|
5 / 6113 (0.08%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis Ischaemic
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis Microscopic
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colonic Pseudo-Obstruction
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colonic Stenosis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Constipation
|
|
|
subjects affected / exposed
|
9 / 6113 (0.15%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Crohn's Disease
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dental Pulp Disorder
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic Gastroparesis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diaphragmatic Hernia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
subjects affected / exposed
|
8 / 6113 (0.13%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Diverticular Perforation
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Diverticulum
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal Ulcer
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal Ulcer Haemorrhage
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterovesical Fistula
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erosive Duodenitis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erosive Oesophagitis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Faecaloma
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Food Poisoning
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric Disorder
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric Haemorrhage
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric Ulcer
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric Ulcer Haemorrhage
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric Ulcer Perforation
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
8 / 6113 (0.13%) |
4 / 3057 (0.13%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis Erosive
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroduodenal Ulcer
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis Haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal Amyloidosis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal Haemorrhage
|
|
|
subjects affected / exposed
|
13 / 6113 (0.21%) |
6 / 3057 (0.20%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Gastrointestinal Hypomotility
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal Obstruction
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrooesophageal Reflux Disease
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Haemorrhoids
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hernial Eventration
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiatus Hernia
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileal Stenosis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
6 / 6113 (0.10%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus Paralytic
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired Gastric Emptying
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal Hernia
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal Hernia, Obstructive
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal Haemorrhage
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal Obstruction
|
|
|
subjects affected / exposed
|
6 / 6113 (0.10%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal Perforation
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intra-Abdominal Haemorrhage
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large Intestinal Obstruction
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large Intestine Polyp
|
|
|
subjects affected / exposed
|
5 / 6113 (0.08%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower Gastrointestinal Haemorrhage
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Melaena
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric Artery Thrombosis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric Vein Thrombosis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nausea
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal Obstruction
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Oesophageal Stenosis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal Varices Haemorrhage
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oral Disorder
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic Pseudocyst
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
subjects affected / exposed
|
6 / 6113 (0.10%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis Acute
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
6 / 3057 (0.20%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis Chronic
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis Relapsing
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic Ulcer
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periodontal Disease
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal Adhesions
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal Haemorrhage
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Proctalgia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal Haemorrhage
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal Prolapse
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Small Intestinal Obstruction
|
|
|
subjects affected / exposed
|
5 / 6113 (0.08%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spigelian Hernia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subileus
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis Mesenteric Vessel
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Umbilical Hernia
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical Hernia, Obstructive
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper Gastrointestinal Haemorrhage
|
|
|
subjects affected / exposed
|
5 / 6113 (0.08%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Varices Oesophageal
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Volvulus
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vomiting
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Bile Duct Obstruction
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile Duct Stenosis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile Duct Stone
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis Acute
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
subjects affected / exposed
|
7 / 6113 (0.11%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis Acute
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
7 / 3057 (0.23%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis Chronic
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
7 / 6113 (0.11%) |
6 / 3057 (0.20%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cirrhosis Alcoholic
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder Polyp
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic Cirrhosis
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic Cyst
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic Failure
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Hepatitis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis Acute
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatorenal Syndrome
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocholecystis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Angioedema
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decubitus Ulcer
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis Contact
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic Foot
|
|
|
subjects affected / exposed
|
24 / 6113 (0.39%) |
13 / 3057 (0.43%) |
occurrences causally related to treatment / all
|
0 / 25 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic Ulcer
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ecchymosis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eczema
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hidradenitis
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash Erythematous
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin Necrosis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin Ulcer
|
|
|
subjects affected / exposed
|
11 / 6113 (0.18%) |
7 / 3057 (0.23%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Stevens-Johnson Syndrome
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
Azotaemia
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Bladder Mass
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder Neck Obstruction
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder Outlet Obstruction
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus Ureteric
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus Urinary
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis Interstitial
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic Nephropathy
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematuria
|
|
|
subjects affected / exposed
|
8 / 6113 (0.13%) |
6 / 3057 (0.20%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lupus Nephritis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Micturition Disorder
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
9 / 6113 (0.15%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrotic Syndrome
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive Uropathy
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Proteinuria
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal Failure
|
|
|
subjects affected / exposed
|
7 / 6113 (0.11%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Renal Failure Acute
|
|
|
subjects affected / exposed
|
31 / 6113 (0.51%) |
8 / 3057 (0.26%) |
occurrences causally related to treatment / all
|
0 / 35 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Renal Failure Chronic
|
|
|
subjects affected / exposed
|
17 / 6113 (0.28%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Renal Haemorrhage
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal Impairment
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal Injury
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal Tubular Necrosis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Strangury
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress Urinary Incontinence
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tubulointerstitial Nephritis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric Stenosis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral Stenosis
|
|
|
subjects affected / exposed
|
7 / 6113 (0.11%) |
6 / 3057 (0.20%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary Incontinence
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary Retention
|
|
|
subjects affected / exposed
|
5 / 6113 (0.08%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinoma
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vesicocutaneous Fistula
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Adrenal Insufficiency
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Goitre
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperparathyroidism
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperparathyroidism Primary
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid Mass
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Ankylosing Spondylitis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Arthralgia
|
|
|
subjects affected / exposed
|
10 / 6113 (0.16%) |
4 / 3057 (0.13%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthrofibrosis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthropathy
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back Pain
|
|
|
subjects affected / exposed
|
8 / 6113 (0.13%) |
8 / 3057 (0.26%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical Spinal Stenosis
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondropathy
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic Recurrent Multifocal Osteomyelitis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Collagen Disorder
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Costochondritis
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fistula
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Exostosis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot Deformity
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture Nonunion
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gouty Arthritis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral Disc Degeneration
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral Disc Disorder
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral Disc Protrusion
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint Instability
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint Swelling
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar Spinal Stenosis
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mobility Decreased
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle Necrosis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle Spasms
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal Chest Pain
|
|
|
subjects affected / exposed
|
5 / 6113 (0.08%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal Pain
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myalgia
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neck Pain
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteitis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
subjects affected / exposed
|
47 / 6113 (0.77%) |
19 / 3057 (0.62%) |
occurrences causally related to treatment / all
|
0 / 51 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain In Extremity
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudarthrosis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psoriatic Arthropathy
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Rotator Cuff Syndrome
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scoliosis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal Column Stenosis
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylitis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal Osteoarthritis
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendonitis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tenosynovitis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Abdominal Hernia Gangrenous
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal Infection
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal Sepsis
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Abdominal Wall Abscess
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess Limb
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal Abscess
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
subjects affected / exposed
|
5 / 6113 (0.08%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis Perforated
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous Graft Site Abscess
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis Bacterial
|
|
|
subjects affected / exposed
|
11 / 6113 (0.18%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis Infective
|
|
|
subjects affected / exposed
|
8 / 6113 (0.13%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asymptomatic Bacteriuria
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atypical Mycobacterial Infection
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
subjects affected / exposed
|
8 / 6113 (0.13%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial Infection
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial Sepsis
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial Tracheitis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Beta Haemolytic Streptococcal Infection
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary Sepsis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Breast Abscess
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast Cellulitis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
subjects affected / exposed
|
11 / 6113 (0.18%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Bronchopneumonia
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis Infective
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Candida Sepsis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cellulitis
|
|
|
subjects affected / exposed
|
63 / 6113 (1.03%) |
36 / 3057 (1.18%) |
occurrences causally related to treatment / all
|
1 / 78 |
0 / 41 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic Hepatitis C
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium Difficile Colitis
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium Difficile Infection
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dengue Fever
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermo-Hypodermitis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device Related Infection
|
|
|
subjects affected / exposed
|
18 / 6113 (0.29%) |
12 / 3057 (0.39%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Diabetic Foot Infection
|
|
|
subjects affected / exposed
|
26 / 6113 (0.43%) |
9 / 3057 (0.29%) |
occurrences causally related to treatment / all
|
0 / 30 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Diabetic Gangrene
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea Infectious
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Disseminated Tuberculosis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Diverticulitis
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Empyema
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis Bacterial
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterobacter Pneumonia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis Bacterial
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis Infectious
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia Bacteraemia
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia Sepsis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia Urinary Tract Infection
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gangrene
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric Infection
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
10 / 6113 (0.16%) |
6 / 3057 (0.20%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis Viral
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Genital Herpes
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft Infection
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin Abscess
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma Infection
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic Cyst Infection
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes Virus Infection
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes Zoster
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implant Site Infection
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incision Site Infection
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected Skin Ulcer
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection In An Immunocompromised Host
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective Exacerbation Of Bronchiectasis
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective Exacerbation Of Chronic Obstructive Airways Disease
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective Spondylitis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza
|
|
|
subjects affected / exposed
|
5 / 6113 (0.08%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral Discitis
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint Abscess
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kidney Infection
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver Abscess
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lobar Pneumonia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Localised Infection
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
4 / 3057 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower Respiratory Tract Infection
|
|
|
subjects affected / exposed
|
7 / 6113 (0.11%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower Respiratory Tract Infection Viral
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung Infection
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mediastinitis
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mumps
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mycobacterium Avium Complex Infection
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nail Infection
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurological Infection
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurosyphilis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orchitis
|
|
|
subjects affected / exposed
|
6 / 6113 (0.10%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
subjects affected / exposed
|
27 / 6113 (0.44%) |
11 / 3057 (0.36%) |
occurrences causally related to treatment / all
|
0 / 29 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis Acute
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis Chronic
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis Externa
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraspinal Abscess
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paronychia
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perihepatic Abscess
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perineal Abscess
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periodontitis
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonsillar Abscess
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
subjects affected / exposed
|
107 / 6113 (1.75%) |
67 / 3057 (2.19%) |
occurrences causally related to treatment / all
|
0 / 122 |
0 / 84 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 9 |
Pneumonia Bacterial
|
|
|
subjects affected / exposed
|
5 / 6113 (0.08%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Pneumonia Necrotising
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia Pneumococcal
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia Staphylococcal
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Poliomyelitis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post Procedural Cellulitis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post Procedural Infection
|
|
|
subjects affected / exposed
|
7 / 6113 (0.11%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post Procedural Pneumonia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post Procedural Sepsis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative Wound Infection
|
|
|
subjects affected / exposed
|
28 / 6113 (0.46%) |
15 / 3057 (0.49%) |
occurrences causally related to treatment / all
|
0 / 30 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic Abscess
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psoas Abscess
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary Sepsis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Pulmonary Tuberculosis
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
5 / 6113 (0.08%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis Acute
|
|
|
subjects affected / exposed
|
7 / 6113 (0.11%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal Abscess
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory Tract Infection
|
|
|
subjects affected / exposed
|
7 / 6113 (0.11%) |
4 / 3057 (0.13%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Scrotal Abscess
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sepsis
|
|
|
subjects affected / exposed
|
34 / 6113 (0.56%) |
18 / 3057 (0.59%) |
occurrences causally related to treatment / all
|
0 / 38 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 5 |
Septic Arthritis Staphylococcal
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Septic Shock
|
|
|
subjects affected / exposed
|
26 / 6113 (0.43%) |
13 / 3057 (0.43%) |
occurrences causally related to treatment / all
|
0 / 27 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 21 |
0 / 8 |
Sinusitis Bacterial
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin Bacterial Infection
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin Infection
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft Tissue Infection
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
4 / 3057 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal Bacteraemia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal Infection
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal Osteomyelitis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal Sepsis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Subcutaneous Abscess
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheitis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheobronchitis
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tuberculosis
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Upper Respiratory Tract Infection
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary Bladder Abscess
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary Tract Infection
|
|
|
subjects affected / exposed
|
91 / 6113 (1.49%) |
38 / 3057 (1.24%) |
occurrences causally related to treatment / all
|
0 / 116 |
0 / 47 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Urinary Tract Infection Bacterial
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary Tract Infection Pseudomonal
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
subjects affected / exposed
|
11 / 6113 (0.18%) |
6 / 3057 (0.20%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Viral Infection
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral Upper Respiratory Tract Infection
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound Infection
|
|
|
subjects affected / exposed
|
5 / 6113 (0.08%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound Infection Bacterial
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Cachexia
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Central Obesity
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decreased Appetite
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dehydration
|
|
|
subjects affected / exposed
|
5 / 6113 (0.08%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes Mellitus
|
|
|
subjects affected / exposed
|
12 / 6113 (0.20%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Diabetes Mellitus Inadequate Control
|
|
|
subjects affected / exposed
|
8 / 6113 (0.13%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic Complication
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Diabetic Ketoacidosis
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrolyte Imbalance
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fluid Overload
|
|
|
subjects affected / exposed
|
4 / 6113 (0.07%) |
5 / 3057 (0.16%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gout
|
|
|
subjects affected / exposed
|
5 / 6113 (0.08%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperamylasaemia
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
10 / 6113 (0.16%) |
6 / 3057 (0.20%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemic Hyperosmolar Nonketotic Syndrome
|
|
|
subjects affected / exposed
|
3 / 6113 (0.05%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
subjects affected / exposed
|
5 / 6113 (0.08%) |
4 / 3057 (0.13%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperuricaemia
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypervolaemia
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
11 / 6113 (0.18%) |
6 / 3057 (0.20%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
6 / 6113 (0.10%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
1 / 3057 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic Acidosis
|
|
|
subjects affected / exposed
|
0 / 6113 (0.00%) |
3 / 3057 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
Obesity
|
|
|
subjects affected / exposed
|
2 / 6113 (0.03%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 1 Diabetes Mellitus
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
0 / 3057 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 2 Diabetes Mellitus
|
|
|
subjects affected / exposed
|
1 / 6113 (0.02%) |
2 / 3057 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |