Serious adverse events
|
Placebo |
Canagliflozin 100 mg |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
806 / 2197 (36.69%) |
737 / 2200 (33.50%) |
number of deaths (all causes)
|
193 |
164 |
number of deaths resulting from adverse events
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Acute Leukaemia
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Adenocarcinoma Gastric
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Adenocarcinoma of Colon
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
B-Cell Lymphoma
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal Cell Carcinoma
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign Neoplasm of Bladder
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (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
|
4 / 2197 (0.18%) |
5 / 2200 (0.23%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder Neoplasm
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder Transitional Cell Carcinoma
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain Cancer Metastatic
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Brain Neoplasm
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast Cancer
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangiocarcinoma
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Chronic Lymphocytic Leukaemia
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon Adenoma
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon Cancer
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
6 / 2200 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Colon Neoplasm
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Diffuse Large B-Cell Lymphoma
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (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 / 2197 (0.00%) |
1 / 2200 (0.05%) |
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 / 2197 (0.05%) |
0 / 2200 (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
|
1 / 2197 (0.05%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric Neoplasm
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatic Neoplasm
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatocellular Carcinoma
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Invasive Breast Carcinoma
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive Ductal Breast Carcinoma
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive Lobular Breast Carcinoma
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large Intestine Benign Neoplasm
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal Cancer
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung Adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lung Cancer Metastatic
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Lung Neoplasm
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Lung Neoplasm Malignant
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Malignant Melanoma
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant Neoplasm of Unknown Primary Site
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Meningioma Malignant
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to Bone
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to Liver
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastatic Renal Cell Carcinoma
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelodysplastic Syndrome
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Neuroendocrine Tumour
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-Hodgkin's Lymphoma Stage Ii
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal Adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oropharyngeal Squamous Cell Carcinoma
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian Cancer
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian Endometrioid Carcinoma
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic Carcinoma
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pancreatic Carcinoma Metastatic
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
Pancreatic Neoplasm
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Papillary Thyroid Cancer
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal Carcinoma Metastatic
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pituitary Tumour Benign
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasma Cell Myeloma
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate Cancer
|
|
|
subjects affected / exposed
|
4 / 2197 (0.18%) |
8 / 2200 (0.36%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic Adenoma
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal Adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal Adenoma
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal Cancer
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectosigmoid Cancer
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal Cell Carcinoma
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal Cell Carcinoma Stage I
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal Neoplasm
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal Oncocytoma
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary Gland Neoplasm
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Squamous Cell Carcinoma
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous Cell Carcinoma of Lung
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Squamous Cell Carcinoma of Skin
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous Cell Carcinoma of the Vulva
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (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 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Transitional Cell Cancer of Renal Pelvis and Ureter Metastatic
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transitional Cell Cancer of the Renal Pelvis and Ureter
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transitional Cell Carcinoma
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Uterine Cancer
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine Leiomyoma
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Accelerated Hypertension
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic Dissection
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Aortic Stenosis
|
|
|
subjects affected / exposed
|
5 / 2197 (0.23%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Arterial Disorder
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial Insufficiency
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Circulatory Collapse
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Deep Vein Thrombosis
|
|
|
subjects affected / exposed
|
7 / 2197 (0.32%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic Vascular Disorder
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism Arterial
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extremity Necrosis
|
|
|
subjects affected / exposed
|
8 / 2197 (0.36%) |
9 / 2200 (0.41%) |
occurrences causally related to treatment / all
|
1 / 9 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertension
|
|
|
subjects affected / exposed
|
7 / 2197 (0.32%) |
7 / 2200 (0.32%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive Crisis
|
|
|
subjects affected / exposed
|
9 / 2197 (0.41%) |
9 / 2200 (0.41%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypertensive Emergency
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotension
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
4 / 2200 (0.18%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intermittent Claudication
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leriche Syndrome
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphoedema
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrosis Ischaemic
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic Hypotension
|
|
|
subjects affected / exposed
|
5 / 2197 (0.23%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
1 / 6 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral Arterial Occlusive Disease
|
|
|
subjects affected / exposed
|
11 / 2197 (0.50%) |
10 / 2200 (0.45%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral Artery Occlusion
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral Ischaemia
|
|
|
subjects affected / exposed
|
5 / 2197 (0.23%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Peripheral Vascular Disorder
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
5 / 2200 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral Venous Disease
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post Thrombotic Syndrome
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shock Haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Subclavian Artery Stenosis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis Superficial
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular Occlusion
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous Haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (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
|
1 / 2197 (0.05%) |
0 / 2200 (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 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pregnancy, puerperium and perinatal conditions
|
|
|
Abortion Spontaneous
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retained Products of Conception
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
Asthenia
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Atrophy
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac Death
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Chest Discomfort
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest Pain
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complication Associated with Device
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Critical Illness
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cyst
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Death
|
|
|
subjects affected / exposed
|
6 / 2197 (0.27%) |
7 / 2200 (0.32%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 7 |
Drowning
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gait Disturbance
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General Physical Health Deterioration
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised Oedema
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated Hernia
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza Like Illness
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Localised Oedema
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (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 / 2197 (0.09%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Necrobiosis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-Cardiac Chest Pain
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
8 / 2200 (0.36%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema Peripheral
|
|
|
subjects affected / exposed
|
4 / 2197 (0.18%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral Swelling
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden Death
|
|
|
subjects affected / exposed
|
8 / 2197 (0.36%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 3 |
Sudden Cardiac Death
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Systemic Inflammatory Response Syndrome
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
Anaphylactic Reaction
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug Hypersensitivity
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Acquired Phimosis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenomyosis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign Prostatic Hyperplasia
|
|
|
subjects affected / exposed
|
4 / 2197 (0.18%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervix Disorder
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystocele
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erectile Dysfunction
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Genital Swelling
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian Cyst
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postmenopausal Haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectocele
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine Prolapse
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterovaginal Prolapse
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal Prolapse
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Acute Pulmonary Oedema
|
|
|
subjects affected / exposed
|
8 / 2197 (0.36%) |
6 / 2200 (0.27%) |
occurrences causally related to treatment / all
|
0 / 11 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
1 / 3 |
Acute Respiratory Distress Syndrome
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Acute Respiratory Failure
|
|
|
subjects affected / exposed
|
6 / 2197 (0.27%) |
5 / 2200 (0.23%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
Apnoeic Attack
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthma
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis Chronic
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic Obstructive Pulmonary Disease
|
|
|
subjects affected / exposed
|
16 / 2197 (0.73%) |
9 / 2200 (0.41%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic Respiratory Failure
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cough
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea at Rest
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Emphysema
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiccups
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (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 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal Haematoma
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Nasal Polyps
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal Septum Perforation
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pickwickian Syndrome
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural Effusion
|
|
|
subjects affected / exposed
|
6 / 2197 (0.27%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleuritic Pain
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia Aspiration
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Pulmonary Arterial Hypertension
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary Congestion
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary Embolism
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
7 / 2200 (0.32%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Pulmonary Fibrosis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
4 / 2200 (0.18%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary Infarction
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulmonary Mass
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (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
|
7 / 2197 (0.32%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Respiratory Depression
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory Distress
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory Failure
|
|
|
subjects affected / exposed
|
10 / 2197 (0.46%) |
10 / 2200 (0.45%) |
occurrences causally related to treatment / all
|
0 / 12 |
1 / 11 |
deaths causally related to treatment / all
|
0 / 3 |
1 / 4 |
Sleep Apnoea Syndrome
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vocal Cord Leukoplakia
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Affective Disorder
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (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 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Confusional State
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delirium
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Disorientation
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental Status Changes
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Substance-Induced Psychotic Disorder
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicide Attempt
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product issues
|
|
|
Device Malfunction
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Bile Duct Obstruction
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (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
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile Duct Stone
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis Acute
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis Sclerosing
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
subjects affected / exposed
|
5 / 2197 (0.23%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis Acute
|
|
|
subjects affected / exposed
|
4 / 2197 (0.18%) |
5 / 2200 (0.23%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis Chronic
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
5 / 2200 (0.23%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic Cirrhosis
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hepatic Function Abnormal
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic Hepatitis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Aspiration Bronchial
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Biopsy Kidney
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood Creatine Phosphokinase Increased
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood Creatinine Increased
|
|
|
subjects affected / exposed
|
20 / 2197 (0.91%) |
7 / 2200 (0.32%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Blood Glucose Increased
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Blood Osmolarity Decreased
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood Urea Increased
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ejection Fraction Decreased
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glomerular Filtration Rate Decreased
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
5 / 2200 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoglobin Decreased
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
International Normalised Ratio Increased
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Troponin Increased
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Weight Decreased
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (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
|
|
|
Anaesthetic Complication
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ankle Fracture
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical Vertebral Fracture
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest Injury
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Clavicle Fracture
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Concussion
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Contusion
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary Artery Reocclusion
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary Vascular Graft Occlusion
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Craniocerebral Injury
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Expired Product Administered
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial Bones Fracture
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral Neck Fracture
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
4 / 2200 (0.18%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femur Fracture
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
5 / 2200 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibula Fracture
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot Fracture
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foreign Body in Eye
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture Displacement
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head Injury
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip Fracture
|
|
|
subjects affected / exposed
|
5 / 2197 (0.23%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Humerus Fracture
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
4 / 2200 (0.18%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint Dislocation
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
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
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament Rupture
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament Sprain
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb Injury
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniscus Injury
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle Injury
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle Strain
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Overdose
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Patella Fracture
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post Procedural Complication
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post Procedural Haematoma
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post Procedural Haemorrhage
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative Thrombosis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative Wound Complication
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural Intestinal Perforation
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural Pain
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pubis Fracture
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radius Fracture
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rib Fracture
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Road Traffic Accident
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Soft Tissue Injury
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal Compression Fracture
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal Fracture
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sternal Fracture
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress Fracture
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subarachnoid Haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Subdural Haematoma
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Subdural Haemorrhage
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thermal Burn
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Thoracic Vertebral Fracture
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tibia Fracture
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic Intracranial Haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ulna Fracture
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular Graft Occlusion
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound
|
|
|
subjects affected / exposed
|
5 / 2197 (0.23%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound Dehiscence
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound Haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrist Fracture
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Acute Coronary Syndrome
|
|
|
subjects affected / exposed
|
8 / 2197 (0.36%) |
12 / 2200 (0.55%) |
occurrences causally related to treatment / all
|
0 / 8 |
1 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Acute Left Ventricular Failure
|
|
|
subjects affected / exposed
|
4 / 2197 (0.18%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute Myocardial Infarction
|
|
|
subjects affected / exposed
|
38 / 2197 (1.73%) |
38 / 2200 (1.73%) |
occurrences causally related to treatment / all
|
1 / 40 |
1 / 42 |
deaths causally related to treatment / all
|
0 / 10 |
0 / 7 |
Angina Pectoris
|
|
|
subjects affected / exposed
|
14 / 2197 (0.64%) |
21 / 2200 (0.95%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina Unstable
|
|
|
subjects affected / exposed
|
29 / 2197 (1.32%) |
17 / 2200 (0.77%) |
occurrences causally related to treatment / all
|
0 / 33 |
2 / 22 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis Coronary Artery
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
4 / 2200 (0.18%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial Fibrillation
|
|
|
subjects affected / exposed
|
19 / 2197 (0.86%) |
16 / 2200 (0.73%) |
occurrences causally related to treatment / all
|
0 / 22 |
1 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Atrial Flutter
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular Block
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular Block Complete
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular Block First Degree
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brugada Syndrome
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac Arrest
|
|
|
subjects affected / exposed
|
7 / 2197 (0.32%) |
5 / 2200 (0.23%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 4 |
Cardiac Asthma
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac Disorder
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac Failure
|
|
|
subjects affected / exposed
|
50 / 2197 (2.28%) |
34 / 2200 (1.55%) |
occurrences causally related to treatment / all
|
1 / 54 |
1 / 43 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 2 |
Cardiac Failure Acute
|
|
|
subjects affected / exposed
|
6 / 2197 (0.27%) |
6 / 2200 (0.27%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiac Failure Chronic
|
|
|
subjects affected / exposed
|
4 / 2197 (0.18%) |
2 / 2200 (0.09%) |
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
|
48 / 2197 (2.18%) |
24 / 2200 (1.09%) |
occurrences causally related to treatment / all
|
0 / 59 |
2 / 27 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Cardiac Fibrillation
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac Tamponade
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardio-Respiratory Arrest
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
4 / 2200 (0.18%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 4 |
Cardiogenic Shock
|
|
|
subjects affected / exposed
|
8 / 2197 (0.36%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 2 |
Cardiomyopathy
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiorenal Syndrome
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic Left Ventricular Failure
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic Right Ventricular Failure
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (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
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary Artery Disease
|
|
|
subjects affected / exposed
|
23 / 2197 (1.05%) |
9 / 2200 (0.41%) |
occurrences causally related to treatment / all
|
1 / 27 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Coronary Artery Insufficiency
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary Artery Occlusion
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary Artery Stenosis
|
|
|
subjects affected / exposed
|
5 / 2197 (0.23%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive Heart Disease
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ischaemic Cardiomyopathy
|
|
|
subjects affected / exposed
|
6 / 2197 (0.27%) |
4 / 2200 (0.18%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Left Ventricular Failure
|
|
|
subjects affected / exposed
|
5 / 2197 (0.23%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral Valve Incompetence
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial Infarction
|
|
|
subjects affected / exposed
|
27 / 2197 (1.23%) |
22 / 2200 (1.00%) |
occurrences causally related to treatment / all
|
3 / 31 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 11 |
0 / 9 |
Myocardial Ischaemia
|
|
|
subjects affected / exposed
|
8 / 2197 (0.36%) |
8 / 2200 (0.36%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Myocarditis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial Effusion
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial Haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulseless Electrical Activity
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Right Ventricular Failure
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus Node Dysfunction
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular Tachycardia
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tricuspid Valve Incompetence
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular Arrhythmia
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (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 / 2197 (0.05%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular Fibrillation
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Ventricular Tachycardia
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
Amputation Stump Pain
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basilar Migraine
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain Injury
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Brain Oedema
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Carotid Artery Occlusion
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid Artery Stenosis
|
|
|
subjects affected / exposed
|
8 / 2197 (0.36%) |
4 / 2200 (0.18%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carpal Tunnel Syndrome
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cauda Equina Syndrome
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar Haemorrhage
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cerebellar Infarction
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar Stroke
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cerebral Haematoma
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cerebral Haemorrhage
|
|
|
subjects affected / exposed
|
4 / 2197 (0.18%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cerebral Hypoperfusion
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral Infarction
|
|
|
subjects affected / exposed
|
7 / 2197 (0.32%) |
6 / 2200 (0.27%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cerebral Ischaemia
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular Accident
|
|
|
subjects affected / exposed
|
36 / 2197 (1.64%) |
30 / 2200 (1.36%) |
occurrences causally related to treatment / all
|
1 / 36 |
2 / 30 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 3 |
Cervical Radiculopathy
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clonus
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depressed Level of Consciousness
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic Autonomic Neuropathy
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic Hyperosmolar Coma
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic Neuropathy
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dural Arteriovenous Fistula
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolic Cerebral Infarction
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolic Stroke
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial Paralysis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised Tonic-Clonic Seizure
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage Intracranial
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Haemorrhagic Stroke
|
|
|
subjects affected / exposed
|
4 / 2197 (0.18%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Haemorrhagic Transformation Stroke
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
Headache
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic Coma
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic Encephalopathy
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxic-Ischaemic Encephalopathy
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracranial Mass
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ischaemic Cerebral Infarction
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic Neuropathy
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic Stroke
|
|
|
subjects affected / exposed
|
17 / 2197 (0.77%) |
14 / 2200 (0.64%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Lacunar Infarction
|
|
|
subjects affected / exposed
|
4 / 2197 (0.18%) |
4 / 2200 (0.18%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Language Disorder
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar Radiculopathy
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbosacral Radiculopathy
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic Encephalopathy
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelopathy
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
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 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraparesis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parkinson's Disease
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral Sensorimotor Neuropathy
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Piriformis Syndrome
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyneuropathy
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Presyncope
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Progressive Supranuclear Palsy
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radicular Syndrome
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (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
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sciatica
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (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 / 2197 (0.05%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Somnolence
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal Cord Compression
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Status Epilepticus
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Syncope
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
4 / 2200 (0.18%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tension Headache
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thalamic Infarction
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient Ischaemic Attack
|
|
|
subjects affected / exposed
|
4 / 2197 (0.18%) |
10 / 2200 (0.45%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular Encephalopathy
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vasculitis Cerebral
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral Artery Stenosis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vith Nerve Paralysis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
subjects affected / exposed
|
10 / 2197 (0.46%) |
7 / 2200 (0.32%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia Vitamin B12 Deficiency
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bicytopenia
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (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
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic Anaemia
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypochromic Anaemia
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iron Deficiency Anaemia
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenopathy
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrogenic Anaemia
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normochromic Normocytic Anaemia
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normocytic Anaemia
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (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
|
3 / 2197 (0.14%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo Positional
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Amaurosis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angle Closure Glaucoma
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract
|
|
|
subjects affected / exposed
|
9 / 2197 (0.41%) |
8 / 2200 (0.36%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract Subcapsular
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic Retinopathy
|
|
|
subjects affected / exposed
|
4 / 2197 (0.18%) |
7 / 2200 (0.32%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye Haemorrhage
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eyelid Ptosis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glaucoma
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Keratitis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Maculopathy
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neovascular Age-Related Macular Degeneration
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Optic Ischaemic Neuropathy
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal Detachment
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhegmatogenous Retinal Detachment
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tractional Retinal Detachment
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uveitis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vision Blurred
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual Impairment
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous Adhesions
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous Haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
4 / 2200 (0.18%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Abdominal Fat Apron
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal Incarcerated Hernia
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
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
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal Pain Lower
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal Pain Upper
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal Fistula
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal Haemorrhage
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic Gastritis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis Ischaemic
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Constipation
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic Gastroparesis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum Intestinal
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (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
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal Ulcer
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal Ulcer Haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenitis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterovesical Fistula
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epulis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Faeces Discoloured
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Food Poisoning
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric Ulcer
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal Haemorrhage
|
|
|
subjects affected / exposed
|
6 / 2197 (0.27%) |
4 / 2200 (0.18%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrooesophageal Reflux Disease
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoidal Haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Incarcerated Inguinal Hernia
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (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
|
1 / 2197 (0.05%) |
4 / 2200 (0.18%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal Obstruction
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
7 / 2200 (0.32%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Intestinal Perforation
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Large Intestine Polyp
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukoplakia Oral
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower Gastrointestinal Haemorrhage
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melaena
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive Pancreatitis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
4 / 2200 (0.18%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis Acute
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic Ulcer
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic Ulcer Haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal Haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal Polyp
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small Intestinal Haemorrhage
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small Intestinal Obstruction
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Subileus
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Swollen Tongue
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical Hernia
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
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
|
1 / 2197 (0.05%) |
4 / 2200 (0.18%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vomiting
|
|
|
subjects affected / exposed
|
4 / 2197 (0.18%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Angioedema
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic Foot
|
|
|
subjects affected / exposed
|
10 / 2197 (0.46%) |
15 / 2200 (0.68%) |
occurrences causally related to treatment / all
|
0 / 11 |
1 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic Ulcer
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug Eruption
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eczema
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erythema
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Idiopathic Angioedema
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathic Ulcer
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psoriasis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash Generalised
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin Ulcer
|
|
|
subjects affected / exposed
|
8 / 2197 (0.36%) |
18 / 2200 (0.82%) |
occurrences causally related to treatment / all
|
1 / 8 |
1 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Renal and urinary disorders
|
|
|
Acute Kidney Injury
|
|
|
subjects affected / exposed
|
50 / 2197 (2.28%) |
41 / 2200 (1.86%) |
occurrences causally related to treatment / all
|
6 / 52 |
4 / 43 |
deaths causally related to treatment / all
|
0 / 5 |
1 / 3 |
Anuria
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Azotaemia
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder Cyst
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus Urinary
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic Kidney Disease
|
|
|
subjects affected / exposed
|
12 / 2197 (0.55%) |
12 / 2200 (0.55%) |
occurrences causally related to treatment / all
|
1 / 14 |
1 / 13 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Diabetic Nephropathy
|
|
|
subjects affected / exposed
|
10 / 2197 (0.46%) |
12 / 2200 (0.55%) |
occurrences causally related to treatment / all
|
0 / 11 |
2 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
End Stage Renal Disease
|
|
|
subjects affected / exposed
|
23 / 2197 (1.05%) |
16 / 2200 (0.73%) |
occurrences causally related to treatment / all
|
1 / 24 |
3 / 17 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 4 |
Glomerulonephritis Chronic
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematuria
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephropathy
|
|
|
subjects affected / exposed
|
4 / 2197 (0.18%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Nephrotic Syndrome
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurogenic Bladder
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal Artery Stenosis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal Colic
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
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
|
9 / 2197 (0.41%) |
5 / 2200 (0.23%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Renal Impairment
|
|
|
subjects affected / exposed
|
7 / 2197 (0.32%) |
10 / 2200 (0.45%) |
occurrences causally related to treatment / all
|
1 / 7 |
2 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Renal Injury
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal Tubular Necrosis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress Urinary Incontinence
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureterolithiasis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral Stenosis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary Retention
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary Tract Obstruction
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Goitre
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperparathyroidism
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperthyroidism
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (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 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inappropriate Antidiuretic Hormone Secretion
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid Mass
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Arthralgia
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back Pain
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical Spinal Stenosis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest Wall Haematoma
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gouty Arthritis
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemarthrosis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral Disc Degeneration
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral Disc Displacement
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (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
|
5 / 2197 (0.23%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar Spinal Stenosis
|
|
|
subjects affected / exposed
|
5 / 2197 (0.23%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscular Weakness
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal Chest Pain
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal Pain
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathic Arthropathy
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteitis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteitis Deformans
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (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
|
11 / 2197 (0.50%) |
10 / 2200 (0.45%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteochondrosis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in Extremity
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periarthritis
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rotator Cuff Syndrome
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal Column Stenosis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal Disorder
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal Osteoarthritis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
4 / 2200 (0.18%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Symphysiolysis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic Lupus Erythematosus
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Trigger Finger
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral Foraminal Stenosis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Abdominal Abscess
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal Sepsis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Abscess Limb
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal Wall Abscess
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute Hepatitis B
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis Perforated
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous Fistula Site Infection
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis Bacterial
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atypical Pneumonia
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
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 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial Pyelonephritis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial Sepsis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchiolitis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
subjects affected / exposed
|
7 / 2197 (0.32%) |
5 / 2200 (0.23%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis Viral
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Campylobacter Colitis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
subjects affected / exposed
|
26 / 2197 (1.18%) |
18 / 2200 (0.82%) |
occurrences causally related to treatment / all
|
1 / 28 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cellulitis Staphylococcal
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic Sinusitis
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium Difficile Colitis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium Difficile Infection
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dengue Fever
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device Related Infection
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic Foot Infection
|
|
|
subjects affected / exposed
|
4 / 2197 (0.18%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic Gangrene
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
5 / 2200 (0.23%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
4 / 2200 (0.18%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysentery
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear Infection
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Empyema
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endophthalmitis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis Infectious
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterobacter Infection
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis Bacterial
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epididymitis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
subjects affected / exposed
|
5 / 2197 (0.23%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Escherichia Sepsis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Furuncle
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gangrene
|
|
|
subjects affected / exposed
|
15 / 2197 (0.68%) |
10 / 2200 (0.45%) |
occurrences causally related to treatment / all
|
3 / 20 |
0 / 11 |
deaths causally related to treatment / all
|
2 / 2 |
0 / 0 |
Gas Gangrene
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
19 / 2197 (0.86%) |
6 / 2200 (0.27%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis Bacterial
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis Viral
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal Bacterial Infection
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Giardiasis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft Infection
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin Abscess
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemophilus Infection
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic Echinococciasis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes Zoster
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (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
|
6 / 2197 (0.27%) |
5 / 2200 (0.23%) |
occurrences causally related to treatment / all
|
0 / 6 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection in An Immunocompromised Host
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Infective Exacerbation of Chronic Obstructive Airways Disease
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral Discitis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Keratitis Fungal
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngitis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver Abscess
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Localised Infection
|
|
|
subjects affected / exposed
|
6 / 2197 (0.27%) |
6 / 2200 (0.27%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower Respiratory Tract Infection
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung Infection
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mediastinitis
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Meningitis Bacterial
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Necrotising Fasciitis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Onychomycosis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Opisthorchiasis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orchitis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
subjects affected / exposed
|
11 / 2197 (0.50%) |
11 / 2200 (0.50%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis Acute
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis Chronic
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perineal Abscess
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periodontitis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal Abscess
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
subjects affected / exposed
|
86 / 2197 (3.91%) |
63 / 2200 (2.86%) |
occurrences causally related to treatment / all
|
1 / 104 |
1 / 72 |
deaths causally related to treatment / all
|
0 / 15 |
1 / 13 |
Pneumonia Bacterial
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia Influenzal
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia Pneumococcal
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia Staphylococcal
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia Streptococcal
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia Viral
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative Wound Infection
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudomonas Bronchitis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary Sepsis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
5 / 2197 (0.23%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
3 / 5 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis Acute
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
4 / 2200 (0.18%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis Chronic
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal Abscess
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory Syncytial Virus Bronchiolitis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (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
|
2 / 2197 (0.09%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory Tract Infection Viral
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhinitis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scrotal Abscess
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scrub Typhus
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sepsis
|
|
|
subjects affected / exposed
|
12 / 2197 (0.55%) |
11 / 2200 (0.50%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 2 |
Septic Shock
|
|
|
subjects affected / exposed
|
12 / 2197 (0.55%) |
5 / 2200 (0.23%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 5 |
Soft Tissue Infection
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal Bacteraemia
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal Infection
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal Sepsis
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcal Infection
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous Abscess
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsillitis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth Abscess
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheobronchitis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper Respiratory Tract Infection
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary Tract Infection
|
|
|
subjects affected / exposed
|
21 / 2197 (0.96%) |
25 / 2200 (1.14%) |
occurrences causally related to treatment / all
|
9 / 25 |
12 / 30 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Urinary Tract Infection Fungal
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Viral Infection
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral Upper Respiratory Tract Infection
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound Infection
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
6 / 2200 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Cachexia
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dehydration
|
|
|
subjects affected / exposed
|
8 / 2197 (0.36%) |
4 / 2200 (0.18%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Diabetes Mellitus
|
|
|
subjects affected / exposed
|
10 / 2197 (0.46%) |
5 / 2200 (0.23%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes Mellitus Inadequate Control
|
|
|
subjects affected / exposed
|
12 / 2197 (0.55%) |
7 / 2200 (0.32%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Diabetic Ketoacidosis
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
9 / 2200 (0.41%) |
occurrences causally related to treatment / all
|
0 / 2 |
2 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Diabetic Ketosis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Diabetic Metabolic Decompensation
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrolyte Imbalance
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fluid Overload
|
|
|
subjects affected / exposed
|
4 / 2197 (0.18%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fluid Retention
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
11 / 2197 (0.50%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 11 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemic Hyperosmolar Nonketotic Syndrome
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
subjects affected / exposed
|
10 / 2197 (0.46%) |
10 / 2200 (0.45%) |
occurrences causally related to treatment / all
|
0 / 10 |
4 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperlipidaemia
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
11 / 2197 (0.50%) |
17 / 2200 (0.77%) |
occurrences causally related to treatment / all
|
3 / 11 |
6 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
3 / 2197 (0.14%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
4 / 2197 (0.18%) |
3 / 2200 (0.14%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypophagia
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoproteinaemia
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ketoacidosis
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lactic Acidosis
|
|
|
subjects affected / exposed
|
0 / 2197 (0.00%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic Acidosis
|
|
|
subjects affected / exposed
|
6 / 2197 (0.27%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Metabolic Disorder
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
0 / 2200 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obesity
|
|
|
subjects affected / exposed
|
1 / 2197 (0.05%) |
2 / 2200 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 2 Diabetes Mellitus
|
|
|
subjects affected / exposed
|
2 / 2197 (0.09%) |
1 / 2200 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |