Serious adverse events
|
Enzalutamide |
Placebo Subjects Crossover to Enzalutamide |
Placebo |
Total subjects affected by serious adverse events
|
|
|
|
subjects affected / exposed
|
384 / 871 (44.09%) |
104 / 234 (44.44%) |
229 / 844 (27.13%) |
number of deaths (all causes)
|
699 |
166 |
550 |
number of deaths resulting from adverse events
|
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
Metastatic pain
|
|
|
|
subjects affected / exposed
|
18 / 871 (2.07%) |
4 / 234 (1.71%) |
17 / 844 (2.01%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 4 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cancer pain
|
|
|
|
subjects affected / exposed
|
3 / 871 (0.34%) |
2 / 234 (0.85%) |
3 / 844 (0.36%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric cancer
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Transitional cell carcinoma
|
|
|
|
subjects affected / exposed
|
4 / 871 (0.46%) |
2 / 234 (0.85%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Malignant pleural effusion
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to central nervous system
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to liver
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
2 / 844 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to meninges
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
1 / 234 (0.43%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to soft tissue
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to spine
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer metastatic
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
2 / 844 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
Rectal cancer
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
1 / 234 (0.43%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
Tonsil cancer
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma gastric
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal cancer
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colorectal cancer
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatocellular carcinoma
|
|
|
|
subjects affected / exposed
|
3 / 871 (0.34%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal adenocarcinoma
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung neoplasm malignant
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to bladder
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to bone
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to bone marrow
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to breast
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to lung
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
2 / 234 (0.85%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Metastases to peritoneum
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neuroendocrine carcinoma of the skin
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteosarcoma
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal cell carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Small cell lung cancer limited stage
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thyroid adenoma
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tumour associated fever
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tumour embolism
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
Tumour pain
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
B-cell lymphoma
|
|
|
|
subjects affected / exposed
|
3 / 871 (0.34%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal stromal tumour
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myelodysplastic syndrome
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute Myeloid Leukaemia
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Basal Cell Carcinoma
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain Neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colorectal Adenocarcinoma
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colorectal Cancer Metastatic
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Diffuse Large B-Cell Lymphoma
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric Cancer Recurrent
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Gastrointestinal Cancer Metastatic
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Glioblastoma Multiforme
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases To Chest Wall
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases To Penis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastatic Neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myxofibrosarcoma
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-Hodgkin's Lymphoma
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Plasma Cell Myeloma
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Small Cell Lung Cancer
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Squamous Cell Carcinoma Of Skin
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
Deep vein thrombosis
|
|
|
|
subjects affected / exposed
|
4 / 871 (0.46%) |
0 / 234 (0.00%) |
2 / 844 (0.24%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertension
|
|
|
|
subjects affected / exposed
|
4 / 871 (0.46%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
2 / 4 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypotension
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic aneurysm
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic aneurysm rupture
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Hypovolaemic shock
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lymphoedema
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vena cava thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic stenosis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Phlebitis
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subclavian artery stenosis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aneurysm
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral Artery Stenosis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
|
Cancer hormonal therapy
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pain management
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Knee Arthroplasty
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Radical Cystectomy
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Umbilical Hernia Repair
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
General physical health deterioration
|
|
|
|
subjects affected / exposed
|
15 / 871 (1.72%) |
6 / 234 (2.56%) |
10 / 844 (1.18%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 6 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 4 |
0 / 4 |
Disease progression
|
|
|
|
subjects affected / exposed
|
10 / 871 (1.15%) |
11 / 234 (4.70%) |
7 / 844 (0.83%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 11 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 10 |
0 / 11 |
0 / 6 |
Death
|
|
|
|
subjects affected / exposed
|
5 / 871 (0.57%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 1 |
Oedema peripheral
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
3 / 844 (0.36%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fatigue
|
|
|
|
subjects affected / exposed
|
5 / 871 (0.57%) |
2 / 234 (0.85%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pain
|
|
|
|
subjects affected / exposed
|
3 / 871 (0.34%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Performance status decreased
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
2 / 844 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Pyrexia
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
3 / 234 (1.28%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Asthenia
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
5 / 234 (2.14%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chest pain
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device dislocation
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
1 / 234 (0.43%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Drowning
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Generalized oedema
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Medical device complication
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oedema
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sudden death
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Suprapubic pain
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adverse drug reaction
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device occlusion
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Local swelling
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device Malfunction
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Medical Device Pain
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Multi-Organ Failure
|
|
|
|
subjects affected / exposed
|
3 / 871 (0.34%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
Anaphylactic shock
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Drug hypersensitivity
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
Benign prostatic hyperplasia
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic pain
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic obstruction
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Testicular pain
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Epididymitis
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
Pulmonary embolism
|
|
|
|
subjects affected / exposed
|
6 / 871 (0.69%) |
0 / 234 (0.00%) |
7 / 844 (0.83%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
3 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
|
subjects affected / exposed
|
5 / 871 (0.57%) |
0 / 234 (0.00%) |
3 / 844 (0.36%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Dyspnoea
|
|
|
|
subjects affected / exposed
|
3 / 871 (0.34%) |
0 / 234 (0.00%) |
2 / 844 (0.24%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Epistaxis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute pulmonary oedema
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aspiration
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Asthma
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemothorax
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hydrothorax
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nasal polyps
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Organising pneumonia
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
|
subjects affected / exposed
|
3 / 871 (0.34%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Pneumonitis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
Restrictive pulmonary disease
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tracheal obstruction extrinsic
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
1 / 234 (0.43%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
Confusional state
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
2 / 234 (0.85%) |
4 / 844 (0.47%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Suicide attempt
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
1 / 234 (0.43%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Depression
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Major depression
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Delirium
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
Electrocardiogram QT prolonged
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemoglobin decreased
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Platelet count decreased
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
1 / 234 (0.43%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
2 / 844 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriogram coronary
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coagulation time prolonged
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eastern cooperative oncology group performance status worsened
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
International normalized ratio increased
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Electrocardiogram repolarisation abnormality
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Weight decreased
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Biopsy
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ejection Fraction Decreased
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Electrocardiogram Abnormal
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
Fall
|
|
|
|
subjects affected / exposed
|
12 / 871 (1.38%) |
2 / 234 (0.85%) |
3 / 844 (0.36%) |
occurrences causally related to treatment / all
|
2 / 12 |
2 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
|
subjects affected / exposed
|
7 / 871 (0.80%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
|
subjects affected / exposed
|
3 / 871 (0.34%) |
1 / 234 (0.43%) |
2 / 844 (0.24%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
|
subjects affected / exposed
|
4 / 871 (0.46%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Humerus fracture
|
|
|
|
subjects affected / exposed
|
4 / 871 (0.46%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
|
subjects affected / exposed
|
3 / 871 (0.34%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
|
subjects affected / exposed
|
3 / 871 (0.34%) |
1 / 234 (0.43%) |
2 / 844 (0.24%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
2 / 234 (0.85%) |
2 / 844 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 1 |
Toxicity to various agents
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis radiation
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chest injury
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clavicle fracture
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Extradural haematoma
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Foreign body
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis radiation
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hand fracture
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Head injury
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Radiation oesophagitis
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skeletal injury
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subdural haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic fracture
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic intracranial haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Contrast media reaction
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Contusion
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haematuria
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Procedural pain
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pubis fracture
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Back Injury
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervical Vertebral Fracture
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Joint Injury
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post Procedural Bile Leak
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal Haematoma
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rib Fracture
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal Fracture
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sternal Fracture
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thoracic Vertebral Fracture
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
Atrial fibrillation
|
|
|
|
subjects affected / exposed
|
10 / 871 (1.15%) |
0 / 234 (0.00%) |
6 / 844 (0.71%) |
occurrences causally related to treatment / all
|
2 / 11 |
0 / 0 |
2 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute myocardial infarction
|
|
|
|
subjects affected / exposed
|
11 / 871 (1.26%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
3 / 12 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
1 / 234 (0.43%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
Atrioventricular block
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute coronary syndrome
|
|
|
|
subjects affected / exposed
|
5 / 871 (0.57%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
|
subjects affected / exposed
|
3 / 871 (0.34%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure acute
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Congestive cardiomyopathy
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive heart disease
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sick sinus syndrome
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinus tachycardia
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular tachycardia
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular extrasystoles
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrial Flutter
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
2 / 234 (0.85%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrial Tachycardia
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular Block Complete
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac Arrest
|
|
|
|
subjects affected / exposed
|
3 / 871 (0.34%) |
0 / 234 (0.00%) |
2 / 844 (0.24%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
Cardiac Failure
|
|
|
|
subjects affected / exposed
|
5 / 871 (0.57%) |
3 / 234 (1.28%) |
2 / 844 (0.24%) |
occurrences causally related to treatment / all
|
2 / 6 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
1 / 4 |
0 / 2 |
0 / 0 |
Cardiac Failure Congestive
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
1 / 234 (0.43%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
3 / 4 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 1 |
Cardiopulmonary Failure
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Cardiovascular Insufficiency
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Coronary Artery Disease
|
|
|
|
subjects affected / exposed
|
6 / 871 (0.69%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary Artery Stenosis
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic Cardiomyopathy
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Left Ventricular Failure
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mitral Valve Disease
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mitral Valve Incompetence
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial Infarction
|
|
|
|
subjects affected / exposed
|
6 / 871 (0.69%) |
1 / 234 (0.43%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 6 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Supraventricular Tachycardia
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tricuspid Valve Incompetence
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular Fibrillation
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Wolff-Parkinson-White Syndrome
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
|
Spinal cord compression
|
|
|
|
subjects affected / exposed
|
35 / 871 (4.02%) |
10 / 234 (4.27%) |
25 / 844 (2.96%) |
occurrences causally related to treatment / all
|
0 / 37 |
0 / 10 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Syncope
|
|
|
|
subjects affected / exposed
|
8 / 871 (0.92%) |
3 / 234 (1.28%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
1 / 8 |
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
|
subjects affected / exposed
|
7 / 871 (0.80%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
Cauda equina syndrome
|
|
|
|
subjects affected / exposed
|
4 / 871 (0.46%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nerve root compression
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
2 / 844 (0.24%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
|
subjects affected / exposed
|
6 / 871 (0.69%) |
0 / 234 (0.00%) |
3 / 844 (0.36%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Presyncope
|
|
|
|
subjects affected / exposed
|
3 / 871 (0.34%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Paraesthesia
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
2 / 844 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Paraparesis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ataxia
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain injury
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Cerebral haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral infarction
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervicobrachial syndrome
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coma hepatic
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Dementia
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Memory impairment
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meningorrhagia
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Reversible ischaemic neurological deficit
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal cord ischaemia
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vith nerve disorder
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Complex partial seizures
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neuralgia
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sciatica
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
2 / 844 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervical Cord Compression
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Convulsion
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cranial Nerve Paralysis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Grand Mal Convulsion
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage Intracranial
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Headache
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoxic-Ischaemic Encephalopathy
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lethargy
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Loss Of Consciousness
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neurological Symptom
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sensory Loss
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vith Nerve Paralysis
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dizziness
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Epiduritis
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Monoplegia
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Status Epilepticus
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
Anaemia
|
|
|
|
subjects affected / exposed
|
18 / 871 (2.07%) |
6 / 234 (2.56%) |
9 / 844 (1.07%) |
occurrences causally related to treatment / all
|
1 / 23 |
1 / 10 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Disseminated intravascular coagulation
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
1 / 234 (0.43%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
Iron deficiency anaemia
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemolytic Uraemic Syndrome
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Idiopathic Thrombocytopenic Purpura
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lymphadenopathy
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Platelet Dysfunction
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
|
Vertigo
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
Amaurosis
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cataract
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinal artery occlusion
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eyelid Ptosis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinal Vein Occlusion
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
Constipation
|
|
|
|
subjects affected / exposed
|
5 / 871 (0.57%) |
2 / 234 (0.85%) |
5 / 844 (0.59%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vomiting
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
2 / 844 (0.24%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
|
subjects affected / exposed
|
3 / 871 (0.34%) |
1 / 234 (0.43%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nausea
|
|
|
|
subjects affected / exposed
|
3 / 871 (0.34%) |
2 / 234 (0.85%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
4 / 871 (0.46%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
1 / 234 (0.43%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
2 / 844 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Melaena
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
1 / 234 (0.43%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain lower
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Large intestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peritoneal haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal stenosis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subileus
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal Stenosis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal Ulcer
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ileus
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal Spasm
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peptic Ulcer
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal Haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
2 / 234 (0.85%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
Bile duct obstruction
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis chronic
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic failure
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Hepatic function abnormal
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Jaundice
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Jaundice cholestatic
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bile Duct Stone
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic Cyst
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
Toxic skin eruption
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rash
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Swelling face
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rash Maculo-Papular
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
Urinary retention
|
|
|
|
subjects affected / exposed
|
10 / 871 (1.15%) |
3 / 234 (1.28%) |
13 / 844 (1.54%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 4 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematuria
|
|
|
|
subjects affected / exposed
|
11 / 871 (1.26%) |
3 / 234 (1.28%) |
12 / 844 (1.42%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 5 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
|
subjects affected / exposed
|
8 / 871 (0.92%) |
1 / 234 (0.43%) |
9 / 844 (1.07%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 1 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
1 / 234 (0.43%) |
11 / 844 (1.30%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Renal failure acute
|
|
|
|
subjects affected / exposed
|
6 / 871 (0.69%) |
2 / 234 (0.85%) |
5 / 844 (0.59%) |
occurrences causally related to treatment / all
|
3 / 6 |
0 / 2 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
Ureteric obstruction
|
|
|
|
subjects affected / exposed
|
4 / 871 (0.46%) |
1 / 234 (0.43%) |
4 / 844 (0.47%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Obstructive uropathy
|
|
|
|
subjects affected / exposed
|
5 / 871 (0.57%) |
3 / 234 (1.28%) |
6 / 844 (0.71%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Bladder outlet obstruction
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
3 / 844 (0.36%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postrenal failure
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
3 / 844 (0.36%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Urinary bladder haemorrhage
|
|
|
|
subjects affected / exposed
|
3 / 871 (0.34%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Calculus bladder
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
1 / 234 (0.43%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prerenal failure
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal failure
|
|
|
|
subjects affected / exposed
|
3 / 871 (0.34%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute prerenal failure
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder obstruction
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal failure chronic
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urethral meatus stenosis
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urethral obstruction
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urine flow decreased
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder neck obstruction
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Micturition urgency
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Calculus Ureteric
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal Colic
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urethral Stenosis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary Incontinence
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nephrotic Syndrome
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Calculus Urinary
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
|
Adrenal insufficiency
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Goitre
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Inappropriate antidiuretic hormone secretion
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
Pathological Fracture
|
|
|
|
subjects affected / exposed
|
15 / 871 (1.72%) |
3 / 234 (1.28%) |
6 / 844 (0.71%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Back pain
|
|
|
|
subjects affected / exposed
|
4 / 871 (0.46%) |
0 / 234 (0.00%) |
5 / 844 (0.59%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bone pain
|
|
|
|
subjects affected / exposed
|
3 / 871 (0.34%) |
0 / 234 (0.00%) |
5 / 844 (0.59%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
|
subjects affected / exposed
|
8 / 871 (0.92%) |
2 / 234 (0.85%) |
2 / 844 (0.24%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
|
subjects affected / exposed
|
4 / 871 (0.46%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
1 / 234 (0.43%) |
2 / 844 (0.24%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
3 / 844 (0.36%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthralgia
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neck pain
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
2 / 844 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteolysis
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
2 / 844 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal column stenosis
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
1 / 234 (0.43%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myalgia
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myopathy
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Periostitis
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Groin pain
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bursitis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervical Spinal Stenosis
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Synovial Cyst
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
Pneumonia
|
|
|
|
subjects affected / exposed
|
14 / 871 (1.61%) |
8 / 234 (3.42%) |
7 / 844 (0.83%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 9 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 0 |
Urinary tract infection
|
|
|
|
subjects affected / exposed
|
8 / 871 (0.92%) |
10 / 234 (4.27%) |
5 / 844 (0.59%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 10 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
|
subjects affected / exposed
|
5 / 871 (0.57%) |
4 / 234 (1.71%) |
3 / 844 (0.36%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Sepsis
|
|
|
|
subjects affected / exposed
|
3 / 871 (0.34%) |
1 / 234 (0.43%) |
4 / 844 (0.47%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
|
subjects affected / exposed
|
4 / 871 (0.46%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device related infection
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis perforated
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gallbladder abscess
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis staphylococcal
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Septic shock
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Urinary tract infection fungal
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Viral infection
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound infection
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic sinusitis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute Sinusitis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis Bacterial
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis Infective
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium Difficile Colitis
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium Difficile Sepsis
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia Urinary Tract Infection
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infected Dermal Cyst
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infection
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
3 / 234 (1.28%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Meningitis Pneumococcal
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative Wound Infection
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary Sepsis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis Acute
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper Respiratory Tract Infection
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
2 / 234 (0.85%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
Dehydration
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
1 / 234 (0.43%) |
3 / 844 (0.36%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Decreased appetite
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
1 / 234 (0.43%) |
2 / 844 (0.24%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
|
subjects affected / exposed
|
3 / 871 (0.34%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cachexia
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Fluid retention
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
|
subjects affected / exposed
|
2 / 871 (0.23%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
0 / 234 (0.00%) |
1 / 844 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolic acidosis
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypophagia
|
|
|
|
subjects affected / exposed
|
0 / 871 (0.00%) |
1 / 234 (0.43%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
|
subjects affected / exposed
|
1 / 871 (0.11%) |
0 / 234 (0.00%) |
0 / 844 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |