Serious adverse events
|
Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) |
Group 2: Placebo (Placebo) |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
842 / 16709 (5.04%) |
457 / 8367 (5.46%) |
number of deaths (all causes)
|
105 |
61 |
number of deaths resulting from adverse events
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Benign Renal Neoplasm
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute Myeloid Leukaemia
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Acute Promyelocytic Leukaemia
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Adenocarcinoma of Colon
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
B-Cell Lymphoma
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal Cell Carcinoma
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast Cancer
|
|
|
subjects affected / exposed
|
11 / 16709 (0.07%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Brain Stem Glioma
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cancer Pain
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cerebral Haemangioma
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervix Carcinoma
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cholangiocarcinoma
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
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
|
3 / 16709 (0.02%) |
3 / 8367 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon Cancer Stage I
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal Cancer
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Desmoplastic Melanoma
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile Duct Cancer
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder Squamous Cell Carcinoma Stage Iv
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Bowen's Disease
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain Neoplasm
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Brain Neoplasm Malignant
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast Cancer Stage Ii
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diffuse Large B-Cell Lymphoma
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal Squamous Cell Carcinoma
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial Cancer
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial Cancer Stage I
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial Cancer Stage Ii
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric Cancer
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glioma
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic Cancer
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hepatic Cancer Stage Iv
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatocellular Carcinoma
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hodgkin's Disease
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal Metastasis
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Intraductal Proliferative Breast Lesion
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive Breast Carcinoma
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive Ductal Breast Carcinoma
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive Lobular Breast Carcinoma
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Keratoacanthoma
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large Intestine Benign Neoplasm
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial Adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung Adenocarcinoma
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung Carcinoma Cell Type Unspecified Stage I
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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 Iii
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung Neoplasm Malignant
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphocytic Leukaemia
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant Melanoma
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant Melanoma Stage Iii
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant Melanoma in Situ
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic Gastric Cancer
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastatic Malignant Melanoma
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic Renal Cell Carcinoma
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastatic Squamous Cell Carcinoma
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mucinous Breast Carcinoma
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelodysplastic Syndrome
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm Malignant
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Non-Hodgkin's Lymphoma
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
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 Stage Iv
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Oesophageal Carcinoma
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small Intestine Adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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 Metastatic
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tongue Neoplasm Malignant Stage Unspecified
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic Carcinoma
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
3 / 8367 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Pancreatic Carcinoma Metastatic
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pancreatic Carcinoma Stage Iv
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pituitary Tumour Benign
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasma Cell Myeloma
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
3 / 8367 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleomorphic Adenoma
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polycythaemia Vera
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate Cancer
|
|
|
subjects affected / exposed
|
18 / 16709 (0.11%) |
4 / 8367 (0.05%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate Cancer Metastatic
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal Adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal Cancer Stage Iv
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal Cancer
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal Cell Carcinoma
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin Cancer
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous Cell Carcinoma of Lung
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsil Cancer
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine Cancer
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal Cancer
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral Cancer
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Hypertensive Emergency
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive Crisis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertension
|
|
|
subjects affected / exposed
|
6 / 16709 (0.04%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extravasation Blood
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deep Vein Thrombosis
|
|
|
subjects affected / exposed
|
15 / 16709 (0.09%) |
3 / 8367 (0.04%) |
occurrences causally related to treatment / all
|
4 / 17 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Arteriosclerosis
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial Occlusive Disease
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic Stenosis
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic Dissection
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic Aneurysm
|
|
|
subjects affected / exposed
|
4 / 16709 (0.02%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Shock Haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Shock
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Peripheral Vascular Disorder
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral Ischaemia
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral Artery Thrombosis
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral Artery Stenosis
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
White Coat Hypertension
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral Arterial Occlusive Disease
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic Hypotension
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotension
|
|
|
subjects affected / exposed
|
5 / 16709 (0.03%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive Urgency
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous Thrombosis Limb
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral Artery Aneurysm
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
Hospitalisation
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
|
|
Drowning
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Death
|
|
|
subjects affected / exposed
|
18 / 16709 (0.11%) |
18 / 8367 (0.22%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 18 |
0 / 18 |
Accidental Death
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Asthenia
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest Discomfort
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest Pain
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
4 / 8367 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complication Associated with Device
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug Withdrawal Syndrome
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypothermia
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Malaise
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple Organ Dysfunction Syndrome
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Non-Cardiac Chest Pain
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prosthetic Cardiac Valve Thrombosis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden Death
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Vascular Stent Stenosis
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fatigue
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
Amyloidosis
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaphylactic Reaction
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaphylactic Shock
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug Hypersensitivity
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Social circumstances
|
|
|
Loss of Personal Independence in Daily Activities
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Benign Prostatic Hyperplasia
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
4 / 8367 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian Cyst
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine Prolapse
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterovaginal Prolapse
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Haemothorax
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute Pulmonary Oedema
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute Respiratory Distress Syndrome
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Acute Respiratory Failure
|
|
|
subjects affected / exposed
|
18 / 16709 (0.11%) |
7 / 8367 (0.08%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 3 |
Asthma
|
|
|
subjects affected / exposed
|
4 / 16709 (0.02%) |
5 / 8367 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis Chronic
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Emphysema
|
|
|
subjects affected / exposed
|
4 / 16709 (0.02%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Dyspnoea
|
|
|
subjects affected / exposed
|
6 / 16709 (0.04%) |
3 / 8367 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystic Lung Disease
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cough
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic Obstructive Pulmonary Disease
|
|
|
subjects affected / exposed
|
31 / 16709 (0.19%) |
14 / 8367 (0.17%) |
occurrences causally related to treatment / all
|
1 / 33 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 0 |
Pulmonary Mass
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary Thrombosis
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory Failure
|
|
|
subjects affected / exposed
|
5 / 16709 (0.03%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Sinus Disorder
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrothorax
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
3 / 16709 (0.02%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Interstitial Lung Disease
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pharyngeal Mass
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural Effusion
|
|
|
subjects affected / exposed
|
5 / 16709 (0.03%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleuritic Pain
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumomediastinum
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonitis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
4 / 16709 (0.02%) |
5 / 8367 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax Spontaneous
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary Embolism
|
|
|
subjects affected / exposed
|
29 / 16709 (0.17%) |
9 / 8367 (0.11%) |
occurrences causally related to treatment / all
|
5 / 29 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Pulmonary Haemorrhage
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulmonary Hypertension
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sleep Apnoea Syndrome
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Neurosis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Completed Suicide
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Confusional State
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Drug Abuse
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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 / 16709 (0.00%) |
1 / 8367 (0.01%) |
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
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product issues
|
|
|
Device Loosening
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device Malfunction
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device Pacing Issue
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device Dislocation
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Cholecystitis Chronic
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile Duct Stone
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary Tract Disorder
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis Acute
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
subjects affected / exposed
|
4 / 16709 (0.02%) |
8 / 8367 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis Acute
|
|
|
subjects affected / exposed
|
4 / 16709 (0.02%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic Failure
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatic Haemorrhage
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatic Cirrhosis
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Investigations
|
|
|
Body Temperature Increased
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac Murmur
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Computerised Tomogram Thorax Abnormal
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram Abnormal
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart Rate Increased
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Human Metapneumovirus Test Positive
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sars-Cov-2 Test Positive
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
|
|
Accidental Overdose
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Contusion
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Craniocerebral Injury
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Extradural Haematoma
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol Poisoning
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ankle Fracture
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
4 / 8367 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial Injury
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asbestosis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back Injury
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone Contusion
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical Vertebral Fracture
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clavicle Fracture
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye Contusion
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Face Injury
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint Injury
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
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
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Humerus Fracture
|
|
|
subjects affected / exposed
|
4 / 16709 (0.02%) |
3 / 8367 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip Fracture
|
|
|
subjects affected / exposed
|
6 / 16709 (0.04%) |
3 / 8367 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head Injury
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hand Fracture
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gun Shot Wound
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Foreign Body in Skin or Subcutaneous Tissue
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Forearm Fracture
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot Fracture
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibula Fracture
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femur Fracture
|
|
|
subjects affected / exposed
|
8 / 16709 (0.05%) |
5 / 8367 (0.06%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral Neck Fracture
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
subjects affected / exposed
|
5 / 16709 (0.03%) |
4 / 8367 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial Bones Fracture
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
3 / 8367 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament Rupture
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural Pain
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative Ileus
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post Vaccination Syndrome
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post Procedural Complication
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax Traumatic
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periprosthetic Fracture
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periprocedural Myocardial Infarction
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic Fracture
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Patella Fracture
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neck Injury
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple Fractures
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
3 / 8367 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniscus Injury
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar Vertebral Fracture
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower Limb Fracture
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver Contusion
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb Injury
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural Complication
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thoracic Vertebral Fracture
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tibia Fracture
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxicity to Various Agents
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Traumatic Haematoma
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic Haemothorax
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rib Fracture
|
|
|
subjects affected / exposed
|
10 / 16709 (0.06%) |
4 / 8367 (0.05%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Road Traffic Accident
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Seroma
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
0 / 16709 (0.00%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin Laceration
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin Wound
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skull Fracture
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal Fracture
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural Haematoma
|
|
|
subjects affected / exposed
|
6 / 16709 (0.04%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural Haemorrhage
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon Rupture
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic Intracranial Haematoma
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
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 / 16709 (0.01%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound Dehiscence
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrist Fracture
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic Lung Injury
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
Hypertrophic Cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitello-Intestinal Duct Remnant
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Acute Left Ventricular Failure
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute Coronary Syndrome
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute Myocardial Infarction
|
|
|
subjects affected / exposed
|
17 / 16709 (0.10%) |
10 / 8367 (0.12%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiac Failure Chronic
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina Unstable
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
4 / 8367 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic Valve Incompetence
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic Valve Stenosis
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Arteriosclerosis Coronary Artery
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
24 / 16709 (0.14%) |
13 / 8367 (0.16%) |
occurrences causally related to treatment / all
|
0 / 24 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial Flutter
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial Thrombosis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular Block Complete
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular Block Second Degree
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradyarrhythmia
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac Arrest
|
|
|
subjects affected / exposed
|
8 / 16709 (0.05%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 1 |
Cardiac Failure
|
|
|
subjects affected / exposed
|
7 / 16709 (0.04%) |
4 / 8367 (0.05%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Angina Pectoris
|
|
|
subjects affected / exposed
|
6 / 16709 (0.04%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac Failure Congestive
|
|
|
subjects affected / exposed
|
15 / 16709 (0.09%) |
6 / 8367 (0.07%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Ischaemic Cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac Ventricular Thrombosis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardio-Respiratory Arrest
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Cardiogenic Shock
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic Coronary Syndrome
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Conduction Disorder
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congestive Cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cor Pulmonale
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cor Pulmonale Chronic
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary Artery Disease
|
|
|
subjects affected / exposed
|
14 / 16709 (0.08%) |
11 / 8367 (0.13%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Coronary Artery Occlusion
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary Artery Thrombosis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive Heart Disease
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Interventricular Septum Rupture
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiac Valve Disease
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral Valve Disease
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular Tachycardia
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral Valve Stenosis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial Infarction
|
|
|
subjects affected / exposed
|
23 / 16709 (0.14%) |
12 / 8367 (0.14%) |
occurrences causally related to treatment / all
|
0 / 24 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 11 |
0 / 4 |
Myocardial Ischaemia
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial Effusion
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus Arrest
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
0 / 16709 (0.00%) |
3 / 8367 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus Tachycardia
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress Cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular Tachycardia
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular Arrhythmia
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular Extrasystoles
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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 / 16709 (0.02%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
Cerebrovascular Disorder
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aphasia
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Balance Disorder
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal Ganglia Haemorrhage
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bell's Palsy
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain Injury
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Carotid Artery Disease
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar Stroke
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
2 / 16709 (0.01%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Cerebral Infarction
|
|
|
subjects affected / exposed
|
9 / 16709 (0.05%) |
3 / 8367 (0.04%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral Mass Effect
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cerebral Venous Sinus Thrombosis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrospinal Fluid Leakage
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular Accident
|
|
|
subjects affected / exposed
|
20 / 16709 (0.12%) |
8 / 8367 (0.10%) |
occurrences causally related to treatment / all
|
0 / 20 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
Cervical Radiculopathy
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
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
|
3 / 16709 (0.02%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness Postural
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Epilepsy
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised Tonic-Clonic Seizure
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
0 / 16709 (0.00%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Haemorrhagic Stroke
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hemiparesis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic Encephalopathy
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Intracranial Aneurysm
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Intracranial Mass
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
7 / 16709 (0.04%) |
7 / 8367 (0.08%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lacunar Infarction
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lacunar Stroke
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Loss of Consciousness
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbosacral Radiculopathy
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Syncope
|
|
|
subjects affected / exposed
|
7 / 16709 (0.04%) |
7 / 8367 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myasthenia Gravis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myasthenic Syndrome
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelopathy
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve Compression
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathy Peripheral
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ophthalmic Migraine
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraesthesia
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parkinson's Disease
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Partial Seizures
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Progressive Supranuclear Palsy
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiculopathy
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seizure
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
3 / 8367 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal Claudication
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subarachnoid Haemorrhage
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Monoplegia
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo CNS Origin
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular Dementia
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Trigeminal Neuralgia
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient Ischaemic Attack
|
|
|
subjects affected / exposed
|
15 / 16709 (0.09%) |
11 / 8367 (0.13%) |
occurrences causally related to treatment / all
|
1 / 15 |
1 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient Global Amnesia
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic Encephalopathy
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
subjects affected / exposed
|
5 / 16709 (0.03%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia Megaloblastic
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Disseminated Intravascular Coagulation
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
4 / 16709 (0.02%) |
3 / 8367 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenopathy Mediastinal
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iron Deficiency Anaemia
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
|
|
Vertigo
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
3 / 8367 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Angle Closure Glaucoma
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diplopia
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ocular Myasthenia
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vision Blurred
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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 Hernia
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal Pain
|
|
|
subjects affected / exposed
|
5 / 16709 (0.03%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Abdominal Pain Upper
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal Fissure
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Constipation
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Crohn's Disease
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticular Perforation
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum Intestinal Haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal Perforation
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal Ulcer
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal Ulcer Haemorrhage
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Duodenitis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric Polyps
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric Ulcer
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric Ulcer Haemorrhage
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (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
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic Gastritis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis Erosive
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal Haemorrhage
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Gastrointestinal Perforation
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal Ulcer
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrooesophageal Reflux Disease
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
5 / 16709 (0.03%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal Hernia
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal Hernia Strangulated
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal Obstruction
|
|
|
subjects affected / exposed
|
6 / 16709 (0.04%) |
1 / 8367 (0.01%) |
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
|
2 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Irritable Bowel Syndrome
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large Intestine Perforation
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large Intestine Polyp
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric Panniculitis
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal Haemorrhage
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal Rupture
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis Acute
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic Ulcer Haemorrhage
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal Polyp
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small Intestinal Obstruction
|
|
|
subjects affected / exposed
|
8 / 16709 (0.05%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small Intestinal Perforation
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spigelian Hernia
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tongue Dysplasia
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper Gastrointestinal Haemorrhage
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal Varices Haemorrhage
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
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
|
|
|
Decubitus Ulcer
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
1 / 16709 (0.01%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkeratosis
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
Prerenal Failure
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
4 / 16709 (0.02%) |
4 / 8367 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephritic Syndrome
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
End Stage Renal Disease
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Chronic Kidney Disease
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute Kidney Injury
|
|
|
subjects affected / exposed
|
7 / 16709 (0.04%) |
5 / 8367 (0.06%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Renal Colic
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral Caruncle
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureterolithiasis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal Mass
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal Injury
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal Haemorrhage
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal Failure
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary Incontinence
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary Tract Disorder
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary Retention
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Myxoedema
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypothyroidism
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
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 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pituitary Cyst
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Musculoskeletal Pain
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthralgia
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
3 / 8367 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthropathy
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back Pain
|
|
|
subjects affected / exposed
|
4 / 16709 (0.02%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical Spinal Stenosis
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inclusion Body Myositis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Intervertebral Disc Degeneration
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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 / 16709 (0.02%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint Effusion
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar Spinal Stenosis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
16 / 16709 (0.10%) |
13 / 8367 (0.16%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoporotic Fracture
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polymyalgia Rheumatica
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rheumatoid Arthritis
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rotator Cuff Syndrome
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scoliosis
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft Tissue Necrosis
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal Osteoarthritis
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal Stenosis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
4 / 8367 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral Foraminal Stenosis
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Appendicitis Perforated
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal Abscess
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess Jaw
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess Limb
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal Abscess
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anorectal Cellulitis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis Bacterial
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic Foot Infection
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial Infection
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Beta Haemolytic Streptococcal Infection
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bronchitis
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis Viral
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carbuncle
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
subjects affected / exposed
|
6 / 16709 (0.04%) |
5 / 8367 (0.06%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis Staphylococcal
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium Colitis
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium Difficile Infection
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colonic Abscess
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronavirus Infection
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronavirus Pneumonia
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Covid-19
|
|
|
subjects affected / exposed
|
29 / 16709 (0.17%) |
12 / 8367 (0.14%) |
occurrences causally related to treatment / all
|
0 / 29 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Covid-19 Pneumonia
|
|
|
subjects affected / exposed
|
6 / 16709 (0.04%) |
4 / 8367 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fungaemia
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia Sepsis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epiglottic Abscess
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
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
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterococcal Sepsis
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis Intestinal Perforated
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
subjects affected / exposed
|
5 / 16709 (0.03%) |
5 / 8367 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gangrene
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
5 / 16709 (0.03%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis Salmonella
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis Viral
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Helicobacter Gastritis
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes Zoster
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected Bite
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected Skin Ulcer
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extradural Abscess
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningoencephalitis Herpetic
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung Abscess
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower Respiratory Tract Infection
|
|
|
subjects affected / exposed
|
7 / 16709 (0.04%) |
3 / 8367 (0.04%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Localised Infection
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver Abscess
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral Discitis
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
4 / 8367 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Infectious Pleural Effusion
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metapneumovirus Infection
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia Legionella
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia Influenzal
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia Bacterial
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia Aspiration
|
|
|
subjects affected / exposed
|
5 / 16709 (0.03%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Pneumonia
|
|
|
subjects affected / exposed
|
46 / 16709 (0.28%) |
26 / 8367 (0.31%) |
occurrences causally related to treatment / all
|
0 / 48 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 4 |
Pharyngitis Streptococcal
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Perirectal Abscess
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia Streptococcal
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative Wound Infection
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal Abscess
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhinovirus Infection
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sepsis
|
|
|
subjects affected / exposed
|
15 / 16709 (0.09%) |
9 / 8367 (0.11%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
Wound Infection
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral Labyrinthitis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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
|
0 / 16709 (0.00%) |
3 / 8367 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary Tract Infection
|
|
|
subjects affected / exposed
|
7 / 16709 (0.04%) |
4 / 8367 (0.05%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper Respiratory Tract Infection
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcal Sepsis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal Infection
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinusitis Fungal
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Septic Shock
|
|
|
subjects affected / exposed
|
4 / 16709 (0.02%) |
3 / 8367 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Postoperative Abscess
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Failure to Thrive
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decreased Appetite
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dehydration
|
|
|
subjects affected / exposed
|
5 / 16709 (0.03%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes Mellitus
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes Mellitus Inadequate Control
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic Ketoacidosis
|
|
|
subjects affected / exposed
|
4 / 16709 (0.02%) |
3 / 8367 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrolyte Imbalance
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gout
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
2 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
3 / 16709 (0.02%) |
2 / 8367 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
subjects affected / exposed
|
0 / 16709 (0.00%) |
1 / 8367 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lactic Acidosis
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (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 / 16709 (0.01%) |
3 / 8367 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
1 / 16709 (0.01%) |
0 / 8367 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |