Serious adverse events
|
Placebo |
Omecamtiv Mecarbil |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
2435 / 4101 (59.38%) |
2373 / 4110 (57.74%) |
number of deaths (all causes)
|
1075 |
1074 |
number of deaths resulting from adverse events
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Acute myeloid leukaemia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Adenocarcinoma gastric
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
subjects affected / exposed
|
7 / 4101 (0.17%) |
5 / 4110 (0.12%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Adenocarcinoma pancreas
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenosquamous cell lung cancer stage III
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Adrenal adenoma
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
B-cell lymphoma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Basal cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basosquamous carcinoma
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of testis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder adenocarcinoma stage 0
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neoplasm
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone sarcoma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangiocarcinoma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Colon adenoma
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic lymphocytic leukaemia
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
subjects affected / exposed
|
7 / 4101 (0.17%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Colon cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Colorectal cancer
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Diffuse large B-cell lymphoma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Endometrial adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Essential thrombocythaemia
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric cancer
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gallbladder cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gastrointestinal stromal tumour
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glioblastoma
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glioblastoma multiforme
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cancer
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatic cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypopharyngeal cancer
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Invasive ductal breast carcinoma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Keratoacanthoma
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lipoma
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liposarcoma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma stage II
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung cancer metastatic
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Lung carcinoma cell type unspecified stage III
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung carcinoma cell type unspecified stage IV
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung neoplasm
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lung neoplasm malignant
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
6 / 4110 (0.15%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 5 |
Lymphangiosis carcinomatosa
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lymphoma
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant neoplasm progression
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mediastinum neoplasm
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medullary thyroid cancer
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melanoma recurrent
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to bone
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastases to liver
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to lymph nodes
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to peritoneum
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastasis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic bronchial carcinoma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastatic neoplasm
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Myelodysplastic syndrome
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelofibrosis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasopharyngeal cancer
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Neoplasm malignant
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Neoplasm skin
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroendocrine carcinoma
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroendocrine carcinoma of the skin
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroendocrine tumour of the lung metastatic
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-small cell lung cancer
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Non-small cell lung cancer stage IV
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal carcinoma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Oesophageal neoplasm
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Oesophageal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal squamous cell carcinoma stage IV
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cancer
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pancreatic carcinoma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pancreatic carcinoma metastatic
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Pancreatic neoplasm
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Papillary thyroid cancer
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Penile cancer
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Penile squamous cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Prostate cancer
|
|
|
subjects affected / exposed
|
6 / 4101 (0.15%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer metastatic
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Prostate cancer recurrent
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer stage I
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer stage IV
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic adenoma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal cancer
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Rectal neoplasm
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal neoplasm
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small cell lung cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small cell lung cancer
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Squamous cell carcinoma
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Squamous cell carcinoma of lung
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Squamous cell carcinoma of pharynx
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the cervix
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the tongue
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid adenoma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsil cancer
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transitional cell carcinoma
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ureteric cancer
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Aortic aneurysm
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic aneurysm rupture
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Aortic dissection
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic dissection rupture
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Aortic rupture
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Aortic stenosis
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Arterial disorder
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial haemorrhage
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial occlusive disease
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial perforation
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial stenosis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Axillary vein thrombosis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brachiocephalic vein thrombosis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
7 / 4101 (0.17%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic macroangiopathy
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Distributive shock
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Dry gangrene
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism arterial
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extremity necrosis
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemodynamic instability
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertension
|
|
|
subjects affected / exposed
|
10 / 4101 (0.24%) |
9 / 4110 (0.22%) |
occurrences causally related to treatment / all
|
1 / 10 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive urgency
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoperfusion
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hypotension
|
|
|
subjects affected / exposed
|
37 / 4101 (0.90%) |
49 / 4110 (1.19%) |
occurrences causally related to treatment / all
|
9 / 41 |
2 / 52 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hypovolaemic shock
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
5 / 4110 (0.12%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Iliac artery stenosis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infarction
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jugular vein thrombosis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leriche syndrome
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant hypertension
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic hypertension
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
subjects affected / exposed
|
11 / 4101 (0.27%) |
12 / 4110 (0.29%) |
occurrences causally related to treatment / all
|
2 / 13 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic venous thrombosis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
subjects affected / exposed
|
18 / 4101 (0.44%) |
17 / 4110 (0.41%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Peripheral artery occlusion
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
6 / 4110 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Peripheral ischaemia
|
|
|
subjects affected / exposed
|
14 / 4101 (0.34%) |
9 / 4110 (0.22%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Peripheral vascular disorder
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral venous disease
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phlebitis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post thrombotic syndrome
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shock
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Shock haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis superficial
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose vein ruptured
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vasculitis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis limb
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
Appendicectomy
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia prophylaxis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder catheter replacement
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac pacemaker replacement
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac resynchronisation therapy
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary angioplasty
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery bypass
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary revascularisation
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart transplant
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hernia diaphragmatic repair
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip arthroplasty
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hospitalisation
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Implantable defibrillator insertion
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implantable defibrillator removal
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia repair
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Knee arthroplasty
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Percutaneous coronary intervention
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Preoperative care
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toe amputation
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transurethral prostatectomy
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pregnancy, puerperium and perinatal conditions
|
|
|
Ectopic pregnancy
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pregnancy
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
Asthenia
|
|
|
subjects affected / exposed
|
7 / 4101 (0.17%) |
5 / 4110 (0.12%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Cardiac death
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 2 |
Catheter site haemorrhage
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest discomfort
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest pain
|
|
|
subjects affected / exposed
|
22 / 4101 (0.54%) |
15 / 4110 (0.36%) |
occurrences causally related to treatment / all
|
2 / 23 |
1 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complication associated with device
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Death
|
|
|
subjects affected / exposed
|
49 / 4101 (1.19%) |
65 / 4110 (1.58%) |
occurrences causally related to treatment / all
|
2 / 49 |
5 / 65 |
deaths causally related to treatment / all
|
2 / 49 |
5 / 65 |
Discomfort
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug withdrawal syndrome
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fatigue
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gait inability
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Generalised oedema
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypothermia
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated hernia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inflammation
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza like illness
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Infusion site extravasation
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Localised oedema
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malaise
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device site haematoma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device site haemorrhage
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device site thrombosis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
subjects affected / exposed
|
14 / 4101 (0.34%) |
17 / 4110 (0.41%) |
occurrences causally related to treatment / all
|
1 / 14 |
0 / 17 |
deaths causally related to treatment / all
|
1 / 9 |
0 / 10 |
Nodule
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
27 / 4101 (0.66%) |
33 / 4110 (0.80%) |
occurrences causally related to treatment / all
|
0 / 28 |
3 / 41 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
subjects affected / exposed
|
7 / 4101 (0.17%) |
8 / 4110 (0.19%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pacemaker generated arrhythmia
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Performance status decreased
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral swelling
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Physical deconditioning
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumatosis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
subjects affected / exposed
|
6 / 4101 (0.15%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden cardiac death
|
|
|
subjects affected / exposed
|
37 / 4101 (0.90%) |
27 / 4110 (0.66%) |
occurrences causally related to treatment / all
|
2 / 37 |
0 / 27 |
deaths causally related to treatment / all
|
2 / 37 |
0 / 27 |
Sudden death
|
|
|
subjects affected / exposed
|
58 / 4101 (1.41%) |
52 / 4110 (1.27%) |
occurrences causally related to treatment / all
|
3 / 58 |
0 / 52 |
deaths causally related to treatment / all
|
3 / 58 |
0 / 52 |
Swelling face
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic inflammatory response syndrome
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulcer haemorrhage
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent occlusion
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent stenosis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vessel puncture site haemorrhage
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
Anaphylactic shock
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug hypersensitivity
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart transplant rejection
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypersensitivity
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Social circumstances
|
|
|
Physical assault
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Victim of homicide
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Benign prostatic hyperplasia
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
5 / 4110 (0.12%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epididymal cyst
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metrorrhagia
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatomegaly
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scrotal oedema
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spermatocele
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Acute pulmonary oedema
|
|
|
subjects affected / exposed
|
10 / 4101 (0.24%) |
10 / 4110 (0.24%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Acute respiratory distress syndrome
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Acute respiratory failure
|
|
|
subjects affected / exposed
|
18 / 4101 (0.44%) |
20 / 4110 (0.49%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Aspiration
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Asthma
|
|
|
subjects affected / exposed
|
6 / 4101 (0.15%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthma-chronic obstructive pulmonary disease overlap syndrome
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchial disorder
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis chronic
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchopneumopathy
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
38 / 4101 (0.93%) |
63 / 4110 (1.53%) |
occurrences causally related to treatment / all
|
0 / 54 |
0 / 81 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 3 |
Chronic respiratory disease
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystic lung disease
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
subjects affected / exposed
|
31 / 4101 (0.76%) |
28 / 4110 (0.68%) |
occurrences causally related to treatment / all
|
0 / 41 |
2 / 34 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 4 |
Dyspnoea at rest
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Dyspnoea exertional
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
5 / 4110 (0.12%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemothorax
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hydrothorax
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypercapnia
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypoxia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Idiopathic pulmonary fibrosis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lung consolidation
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lung infiltration
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal polyps
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paranasal cyst
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural disorder
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
14 / 4101 (0.34%) |
11 / 4110 (0.27%) |
occurrences causally related to treatment / all
|
0 / 16 |
1 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pneumonia aspiration
|
|
|
subjects affected / exposed
|
6 / 4101 (0.15%) |
6 / 4110 (0.15%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Pneumonitis
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pneumothorax
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax spontaneous
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary arterial hypertension
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary artery thrombosis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Pulmonary congestion
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
13 / 4101 (0.32%) |
20 / 4110 (0.49%) |
occurrences causally related to treatment / all
|
0 / 13 |
1 / 21 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 3 |
Pulmonary haemorrhage
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary hypertension
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pulmonary mass
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
subjects affected / exposed
|
12 / 4101 (0.29%) |
14 / 4110 (0.34%) |
occurrences causally related to treatment / all
|
0 / 14 |
1 / 17 |
deaths causally related to treatment / all
|
0 / 3 |
1 / 3 |
Pulmonary vascular disorder
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory acidosis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory arrest
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Respiratory disorder
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
subjects affected / exposed
|
18 / 4101 (0.44%) |
22 / 4110 (0.54%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 8 |
Sleep apnoea syndrome
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stridor
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsillar hypertrophy
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheal stenosis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheomalacia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Alcohol abuse
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol withdrawal syndrome
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcoholism
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety disorder
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Behaviour disorder
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bipolar disorder
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Communication disorder
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 2 |
Confusional state
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Conversion disorder
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delirium
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delusion
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Disorientation
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hallucination
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Major depression
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental disorder
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Panic attack
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Personality disorder
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychotic behaviour
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicidal ideation
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicide attempt
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product issues
|
|
|
Device alarm issue
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device dislocation
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device electrical impedance issue
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device extrusion
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device inappropriate shock delivery
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device lead damage
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device lead issue
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device leakage
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device malfunction
|
|
|
subjects affected / exposed
|
6 / 4101 (0.15%) |
6 / 4110 (0.15%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device occlusion
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device physical property issue
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device power source issue
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device signal detection issue
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device stimulation issue
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lead dislodgement
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oversensing
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Undersensing
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Acute hepatic failure
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Alcoholic liver disease
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Autoimmune hepatitis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct obstruction
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct stone
|
|
|
subjects affected / exposed
|
6 / 4101 (0.15%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary colic
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac cirrhosis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
6 / 4110 (0.15%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis acute
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
subjects affected / exposed
|
9 / 4101 (0.22%) |
11 / 4110 (0.27%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
subjects affected / exposed
|
18 / 4101 (0.44%) |
11 / 4110 (0.27%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis chronic
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
11 / 4101 (0.27%) |
9 / 4110 (0.22%) |
occurrences causally related to treatment / all
|
1 / 12 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis obstructive
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholestasis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cirrhosis alcoholic
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Congestive hepatopathy
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug-induced liver injury
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
5 / 4110 (0.12%) |
occurrences causally related to treatment / all
|
1 / 2 |
3 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cirrhosis
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
5 / 4110 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Hepatic failure
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
5 / 4110 (0.12%) |
occurrences causally related to treatment / all
|
1 / 4 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic function abnormal
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic ischaemia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic haematoma
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis acute
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatocellular injury
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatorenal failure
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatorenal syndrome
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
1 / 2 |
Hepatotoxicity
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Ischaemic hepatitis
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
5 / 4110 (0.12%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaundice
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaundice cholestatic
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Liver disorder
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver injury
|
|
|
subjects affected / exposed
|
8 / 4101 (0.20%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
2 / 10 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Portal hypertension
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Portal vein thrombosis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Primary biliary cholangitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venoocclusive liver disease
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Alanine aminotransferase increased
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anticoagulation drug level above therapeutic
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
5 / 4110 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anticoagulation drug level below therapeutic
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aspartate aminotransferase increased
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood alkaline phosphatase increased
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood calcium decreased
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatine phosphokinase increased
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood glucose decreased
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Blood lactate dehydrogenase increased
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood magnesium decreased
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood potassium decreased
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac output decreased
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheterisation cardiac
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coagulation time prolonged
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ejection fraction decreased
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram QT prolonged
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HIV antibody positive
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram ST segment elevation
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoglobin decreased
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic enzyme abnormal
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
subjects affected / exposed
|
6 / 4101 (0.15%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
1 / 6 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza A virus test positive
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
International normalised ratio abnormal
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
International normalised ratio decreased
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
International normalised ratio increased
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver function test abnormal
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver function test increased
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oxygen consumption increased
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SARS-CoV-2 test positive
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcus test positive
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transaminases increased
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transplant evaluation
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Troponin increased
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Weight decreased
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
Abdominal wound dehiscence
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Accidental exposure to product by child
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Accidental overdose
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol poisoning
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial bypass thrombosis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula thrombosis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone contusion
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain contusion
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Burns third degree
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carbon monoxide poisoning
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac procedure complication
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac vein perforation
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract traumatic
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clavicle fracture
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Concussion
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Contusion
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dialysis disequilibrium syndrome
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epidural haemorrhage
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eschar
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
subjects affected / exposed
|
7 / 4101 (0.17%) |
10 / 4110 (0.24%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
subjects affected / exposed
|
8 / 4101 (0.20%) |
8 / 4110 (0.19%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
subjects affected / exposed
|
14 / 4101 (0.34%) |
11 / 4110 (0.27%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Foot fracture
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foreign body in eye
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foreign body in gastrointestinal tract
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Fracture displacement
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fractured coccyx
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrostomy tube site complication
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft thrombosis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematuria traumatic
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hand fracture
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head injury
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Hip fracture
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
7 / 4110 (0.17%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Humerus fracture
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
6 / 4110 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyphaema
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Injury corneal
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intentional overdose
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal anastomosis complication
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint injury
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb crushing injury
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb injury
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb traumatic amputation
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple fractures
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple injuries
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Osteophyte fracture
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Overdose
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Patella fracture
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periorbital haemorrhage
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumocephalus
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax traumatic
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural bile leak
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural complication
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural fever
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematuria
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
5 / 4110 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural hypotension
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postpericardiotomy syndrome
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural pneumothorax
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary contusion
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
subjects affected / exposed
|
7 / 4101 (0.17%) |
6 / 4110 (0.15%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Scrotal haematoma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin laceration
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skull fracture
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skull fractured base
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
subjects affected / exposed
|
9 / 4101 (0.22%) |
8 / 4110 (0.19%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Subdural haemorrhage
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Synovial rupture
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon injury
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thermal burn
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
5 / 4110 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic haematoma
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic intracranial haemorrhage
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Upper limb fracture
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral injury
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft complication
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft occlusion
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular procedure complication
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vasoplegia syndrome
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vena cava injury
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Wound
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound complication
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
Congenital megaureter
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocele
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertrophic cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Myocardial bridging
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-compaction cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Acute coronary syndrome
|
|
|
subjects affected / exposed
|
12 / 4101 (0.29%) |
11 / 4110 (0.27%) |
occurrences causally related to treatment / all
|
3 / 12 |
2 / 12 |
deaths causally related to treatment / all
|
0 / 1 |
1 / 2 |
Acute left ventricular failure
|
|
|
subjects affected / exposed
|
16 / 4101 (0.39%) |
9 / 4110 (0.22%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Acute myocardial infarction
|
|
|
subjects affected / exposed
|
64 / 4101 (1.56%) |
71 / 4110 (1.73%) |
occurrences causally related to treatment / all
|
7 / 70 |
3 / 73 |
deaths causally related to treatment / all
|
0 / 16 |
0 / 16 |
Acute right ventricular failure
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Angina pectoris
|
|
|
subjects affected / exposed
|
40 / 4101 (0.98%) |
41 / 4110 (1.00%) |
occurrences causally related to treatment / all
|
5 / 46 |
3 / 46 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
subjects affected / exposed
|
49 / 4101 (1.19%) |
63 / 4110 (1.53%) |
occurrences causally related to treatment / all
|
9 / 52 |
9 / 68 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Aortic valve disease
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve disease mixed
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve incompetence
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve stenosis
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
subjects affected / exposed
|
6 / 4101 (0.15%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Arrhythmia supraventricular
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
subjects affected / exposed
|
7 / 4101 (0.17%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
113 / 4101 (2.76%) |
94 / 4110 (2.29%) |
occurrences causally related to treatment / all
|
5 / 127 |
3 / 112 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Atrial flutter
|
|
|
subjects affected / exposed
|
25 / 4101 (0.61%) |
23 / 4110 (0.56%) |
occurrences causally related to treatment / all
|
1 / 29 |
3 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial tachycardia
|
|
|
subjects affected / exposed
|
9 / 4101 (0.22%) |
9 / 4110 (0.22%) |
occurrences causally related to treatment / all
|
1 / 9 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial thrombosis
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block complete
|
|
|
subjects affected / exposed
|
12 / 4101 (0.29%) |
14 / 4110 (0.34%) |
occurrences causally related to treatment / all
|
1 / 12 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Atrioventricular block second degree
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradyarrhythmia
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
8 / 4110 (0.19%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bundle branch block left
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac amyloidosis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac aneurysm
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
subjects affected / exposed
|
64 / 4101 (1.56%) |
50 / 4110 (1.22%) |
occurrences causally related to treatment / all
|
3 / 66 |
2 / 52 |
deaths causally related to treatment / all
|
1 / 42 |
2 / 46 |
Cardiac asthma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorder
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Cardiac failure
|
|
|
subjects affected / exposed
|
1045 / 4101 (25.48%) |
988 / 4110 (24.04%) |
occurrences causally related to treatment / all
|
26 / 1879 |
30 / 1795 |
deaths causally related to treatment / all
|
2 / 191 |
4 / 190 |
Cardiac failure acute
|
|
|
subjects affected / exposed
|
251 / 4101 (6.12%) |
212 / 4110 (5.16%) |
occurrences causally related to treatment / all
|
10 / 362 |
10 / 308 |
deaths causally related to treatment / all
|
2 / 28 |
0 / 41 |
Cardiac failure chronic
|
|
|
subjects affected / exposed
|
170 / 4101 (4.15%) |
156 / 4110 (3.80%) |
occurrences causally related to treatment / all
|
5 / 236 |
2 / 199 |
deaths causally related to treatment / all
|
1 / 40 |
0 / 33 |
Cardiac failure congestive
|
|
|
subjects affected / exposed
|
154 / 4101 (3.76%) |
147 / 4110 (3.58%) |
occurrences causally related to treatment / all
|
5 / 234 |
7 / 208 |
deaths causally related to treatment / all
|
2 / 19 |
1 / 24 |
Cardiac flutter
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac tamponade
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac valve disease
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
subjects affected / exposed
|
14 / 4101 (0.34%) |
9 / 4110 (0.22%) |
occurrences causally related to treatment / all
|
0 / 14 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 13 |
1 / 7 |
Cardiac ventricular thrombosis
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiogenic shock
|
|
|
subjects affected / exposed
|
68 / 4101 (1.66%) |
75 / 4110 (1.82%) |
occurrences causally related to treatment / all
|
1 / 70 |
5 / 77 |
deaths causally related to treatment / all
|
0 / 30 |
3 / 42 |
Cardiomyopathy
|
|
|
subjects affected / exposed
|
8 / 4101 (0.20%) |
12 / 4110 (0.29%) |
occurrences causally related to treatment / all
|
0 / 8 |
1 / 12 |
deaths causally related to treatment / all
|
0 / 3 |
1 / 2 |
Cardiopulmonary failure
|
|
|
subjects affected / exposed
|
6 / 4101 (0.15%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 3 |
Cardiorenal syndrome
|
|
|
subjects affected / exposed
|
10 / 4101 (0.24%) |
14 / 4110 (0.34%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 3 |
Cardiovascular insufficiency
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Chordae tendinae rupture
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic left ventricular failure
|
|
|
subjects affected / exposed
|
8 / 4101 (0.20%) |
6 / 4110 (0.15%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Chronotropic incompetence
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Conduction disorder
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congestive cardiomyopathy
|
|
|
subjects affected / exposed
|
24 / 4101 (0.59%) |
14 / 4110 (0.34%) |
occurrences causally related to treatment / all
|
0 / 27 |
1 / 20 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Coronary artery disease
|
|
|
subjects affected / exposed
|
24 / 4101 (0.59%) |
26 / 4110 (0.63%) |
occurrences causally related to treatment / all
|
1 / 24 |
0 / 31 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Coronary artery insufficiency
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Coronary artery occlusion
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
subjects affected / exposed
|
10 / 4101 (0.24%) |
6 / 4110 (0.15%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extrasystoles
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive heart disease
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Intracardiac thrombus
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic cardiomyopathy
|
|
|
subjects affected / exposed
|
8 / 4101 (0.20%) |
9 / 4110 (0.22%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Left ventricular dysfunction
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left ventricular failure
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Low cardiac output syndrome
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
subjects affected / exposed
|
8 / 4101 (0.20%) |
9 / 4110 (0.22%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Myocardial fibrosis
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Myocardial infarction
|
|
|
subjects affected / exposed
|
54 / 4101 (1.32%) |
36 / 4110 (0.88%) |
occurrences causally related to treatment / all
|
7 / 56 |
3 / 36 |
deaths causally related to treatment / all
|
3 / 20 |
1 / 16 |
Myocardial ischaemia
|
|
|
subjects affected / exposed
|
10 / 4101 (0.24%) |
12 / 4110 (0.29%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 4 |
Myocarditis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Palpitations
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
1 / 3 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paroxysmal arrhythmia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial haemorrhage
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pericarditis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericarditis constrictive
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postinfarction angina
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Prinzmetal angina
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prosthetic cardiac valve thrombosis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulseless electrical activity
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
1 / 2 |
0 / 0 |
Right ventricular dysfunction
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Right ventricular failure
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus arrest
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus node dysfunction
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
5 / 4110 (0.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus tachycardia
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular extrasystoles
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachyarrhythmia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
11 / 4101 (0.27%) |
8 / 4110 (0.19%) |
occurrences causally related to treatment / all
|
0 / 11 |
1 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachyarrhythmia
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tricuspid valve incompetence
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Trifascicular block
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular arrhythmia
|
|
|
subjects affected / exposed
|
18 / 4101 (0.44%) |
24 / 4110 (0.58%) |
occurrences causally related to treatment / all
|
3 / 21 |
2 / 25 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 1 |
Ventricular extrasystoles
|
|
|
subjects affected / exposed
|
9 / 4101 (0.22%) |
8 / 4110 (0.19%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular fibrillation
|
|
|
subjects affected / exposed
|
49 / 4101 (1.19%) |
30 / 4110 (0.73%) |
occurrences causally related to treatment / all
|
5 / 52 |
3 / 31 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 5 |
Ventricular flutter
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ventricular tachyarrhythmia
|
|
|
subjects affected / exposed
|
7 / 4101 (0.17%) |
7 / 4110 (0.17%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ventricular tachycardia
|
|
|
subjects affected / exposed
|
129 / 4101 (3.15%) |
106 / 4110 (2.58%) |
occurrences causally related to treatment / all
|
12 / 149 |
12 / 138 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 6 |
Nervous system disorders
|
|
|
Alcohol induced persisting dementia
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Altered state of consciousness
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Amnesia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Balance disorder
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain compression
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain hypoxia
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Brain injury
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Brain oedema
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain stem stroke
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid arteriosclerosis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery disease
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery occlusion
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar haemorrhage
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral artery embolism
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cerebral circulatory failure
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haematoma
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cerebral haemorrhage
|
|
|
subjects affected / exposed
|
7 / 4101 (0.17%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Cerebral hypoperfusion
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral infarction
|
|
|
subjects affected / exposed
|
13 / 4101 (0.32%) |
8 / 4110 (0.19%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cerebral ischaemia
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Cerebrovascular accident
|
|
|
subjects affected / exposed
|
29 / 4101 (0.71%) |
25 / 4110 (0.61%) |
occurrences causally related to treatment / all
|
1 / 32 |
0 / 25 |
deaths causally related to treatment / all
|
1 / 6 |
0 / 4 |
Cerebrovascular disorder
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular insufficiency
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cognitive disorder
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coma
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complex regional pain syndrome
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic neuropathy
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness
|
|
|
subjects affected / exposed
|
8 / 4101 (0.20%) |
6 / 4110 (0.15%) |
occurrences causally related to treatment / all
|
2 / 9 |
2 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness postural
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysaesthesia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysarthria
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolic stroke
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Encephalopathy
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised tonic-clonic seizure
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic cerebral infarction
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic stroke
|
|
|
subjects affected / exposed
|
7 / 4101 (0.17%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 1 |
Haemorrhagic transformation stroke
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Headache
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemianopia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic encephalopathy
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocephalus
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemic unconsciousness
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoaesthesia
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic unconsciousness
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
subjects affected / exposed
|
38 / 4101 (0.93%) |
36 / 4110 (0.88%) |
occurrences causally related to treatment / all
|
1 / 40 |
0 / 38 |
deaths causally related to treatment / all
|
1 / 6 |
0 / 10 |
Ischaemic cerebral infarction
|
|
|
subjects affected / exposed
|
7 / 4101 (0.17%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lacunar infarction
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lethargy
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningism
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
5 / 4110 (0.12%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Mononeuritis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Monoplegia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle contractions involuntary
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myoclonus
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuralgia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuromyopathy
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normal pressure hydrocephalus
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic intolerance
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parkinson's disease
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Partial seizures
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral sensorimotor neuropathy
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyneuropathy
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post-traumatic epilepsy
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Presyncope
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
8 / 4110 (0.19%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychogenic seizure
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychomotor disadaptation syndrome
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychomotor hyperactivity
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radicular pain
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sciatica
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sedation
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seizure
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seizure like phenomena
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Status epilepticus
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stroke in evolution
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Subarachnoid haemorrhage
|
|
|
subjects affected / exposed
|
6 / 4101 (0.15%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Syncope
|
|
|
subjects affected / exposed
|
46 / 4101 (1.12%) |
42 / 4110 (1.02%) |
occurrences causally related to treatment / all
|
1 / 51 |
0 / 43 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Thrombotic stroke
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Transient ischaemic attack
|
|
|
subjects affected / exposed
|
24 / 4101 (0.59%) |
17 / 4110 (0.41%) |
occurrences causally related to treatment / all
|
0 / 26 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Trigeminal neuralgia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebrobasilar insufficiency
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo CNS origin
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
subjects affected / exposed
|
28 / 4101 (0.68%) |
34 / 4110 (0.83%) |
occurrences causally related to treatment / all
|
1 / 31 |
0 / 38 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia of chronic disease
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia vitamin B12 deficiency
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood loss anaemia
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coagulopathy
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cold type haemolytic anaemia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypercoagulation
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypochromic anaemia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune thrombocytopenia
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Iron deficiency anaemia
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukopenia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenopathy
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Microcytic anaemia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normochromic anaemia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normochromic normocytic anaemia
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normocytic anaemia
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic infarction
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spontaneous haematoma
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
Deafness unilateral
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden hearing loss
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular disorder
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Amaurosis fugax
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerotic retinopathy
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract
|
|
|
subjects affected / exposed
|
9 / 4101 (0.22%) |
8 / 4110 (0.19%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract diabetic
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic retinopathy
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diplopia
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye inflammation
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glaucoma
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iridodialysis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iris disorder
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular fibrosis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ocular hypertension
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pterygium
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scleromalacia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulcerative keratitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual impairment
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous haematoma
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous haemorrhage
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Abdominal adhesions
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal discomfort
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal distension
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Abdominal hernia
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal incarcerated hernia
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
subjects affected / exposed
|
13 / 4101 (0.32%) |
6 / 4110 (0.15%) |
occurrences causally related to treatment / all
|
1 / 13 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
6 / 4110 (0.15%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abnormal faeces
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute abdomen
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Anal fistula
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anorectal disorder
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ascites
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic gastritis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis microscopic
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ulcerative
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Constipation
|
|
|
subjects affected / exposed
|
7 / 4101 (0.17%) |
5 / 4110 (0.12%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Crohn's disease
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dental caries
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gastroparesis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
subjects affected / exposed
|
12 / 4101 (0.29%) |
6 / 4110 (0.15%) |
occurrences causally related to treatment / all
|
2 / 13 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dieulafoy's vascular malformation
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticular perforation
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epiploic appendagitis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erosive oesophagitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Food poisoning
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric disorder
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric haemorrhage
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric polyps
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
5 / 4110 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer perforation
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
7 / 4101 (0.17%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal angiodysplasia
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorder
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
14 / 4101 (0.34%) |
18 / 4110 (0.44%) |
occurrences causally related to treatment / all
|
0 / 14 |
1 / 19 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Gastrointestinal necrosis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal obstruction
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
subjects affected / exposed
|
7 / 4101 (0.17%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gingival bleeding
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematochezia
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoperitoneum
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic erosive gastritis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hernial eventration
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Ileus paralytic
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired gastric emptying
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated umbilical hernia
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
subjects affected / exposed
|
9 / 4101 (0.22%) |
10 / 4110 (0.24%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Inguinal hernia strangulated
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal angina
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal infarction
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal ischaemia
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Intestinal obstruction
|
|
|
subjects affected / exposed
|
6 / 4101 (0.15%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Intra-abdominal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intussusception
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Irritable bowel syndrome
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic enteritis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower gastrointestinal perforation
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mechanical ileus
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melaena
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric arterial occlusion
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Mesenteric artery embolism
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Mesenteric vascular insufficiency
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nausea
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrotising oesophagitis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive pancreatitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal motility disorder
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal spasm
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Oesophageal varices haemorrhage
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Oesophagitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
9 / 4110 (0.22%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
Pancreatitis haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pancreatolithiasis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer haemorrhage
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal fissure
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal polyp
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal prolapse
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subileus
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis mesenteric vessel
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Tooth disorder
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
9 / 4101 (0.22%) |
10 / 4110 (0.24%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Volvulus
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vomiting
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
6 / 4110 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Angioedema
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blister
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decubitus ulcer
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermal cyst
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis exfoliative
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis exfoliative generalised
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot
|
|
|
subjects affected / exposed
|
6 / 4101 (0.15%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ulcer
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug eruption
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hair growth abnormal
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperhidrosis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peau d'orange
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pemphigoid
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pruritus
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psoriasis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Rash
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin erosion
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin lesion
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin necrosis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
subjects affected / exposed
|
7 / 4101 (0.17%) |
6 / 4110 (0.15%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stasis dermatitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic skin eruption
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
Acute kidney injury
|
|
|
subjects affected / exposed
|
138 / 4101 (3.37%) |
129 / 4110 (3.14%) |
occurrences causally related to treatment / all
|
6 / 161 |
6 / 152 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 8 |
Anuria
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atonic urinary bladder
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Azotaemia
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neck obstruction
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus bladder
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus urinary
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
subjects affected / exposed
|
36 / 4101 (0.88%) |
36 / 4110 (0.88%) |
occurrences causally related to treatment / all
|
1 / 38 |
1 / 41 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Diabetic nephropathy
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
End stage renal disease
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
7 / 4110 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Haematinuria
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematuria
|
|
|
subjects affected / exposed
|
7 / 4101 (0.17%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage urinary tract
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive nephropathy
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Micturition disorder
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephropathy
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Oliguria
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postrenal failure
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal arteriosclerosis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery stenosis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery thrombosis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal colic
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cyst haemorrhage
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure
|
|
|
subjects affected / exposed
|
31 / 4101 (0.76%) |
25 / 4110 (0.61%) |
occurrences causally related to treatment / all
|
1 / 31 |
2 / 26 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
Renal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
subjects affected / exposed
|
29 / 4101 (0.71%) |
25 / 4110 (0.61%) |
occurrences causally related to treatment / all
|
0 / 31 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Renal infarct
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureterolithiasis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral haemorrhage
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Basedow's disease
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Goitre
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypercalcaemia of malignancy
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperthyroidism
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypothyroidism
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroiditis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyrotoxic crisis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Arthralgia
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis reactive
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthropathy
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back pain
|
|
|
subjects affected / exposed
|
6 / 4101 (0.15%) |
7 / 4110 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Compartment syndrome
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Costochondritis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dupuytren's contracture
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Elbow deformity
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial asymmetry
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fasciitis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Flank pain
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gouty arthritis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemarthrosis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma muscle
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc compression
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint effusion
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb discomfort
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mobility decreased
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle spasms
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
10 / 4110 (0.24%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal disorder
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myalgia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myofascial pain syndrome
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteitis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
subjects affected / exposed
|
9 / 4101 (0.22%) |
12 / 4110 (0.29%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteochondritis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteochondrosis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteolysis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoporotic fracture
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyarthritis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polymyalgia rheumatica
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudarthrosis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rheumatoid arthritis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal pain
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Synovitis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tenosynovitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral foraminal stenosis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Abdominal sepsis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess jaw
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Acute endocarditis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute hepatitis B
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendiceal abscess
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis perforated
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerotic gangrene
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atypical pneumonia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
subjects affected / exposed
|
6 / 4101 (0.15%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial infection
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial sepsis
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bacterial tracheitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary sepsis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
subjects affected / exposed
|
24 / 4101 (0.59%) |
25 / 4110 (0.61%) |
occurrences causally related to treatment / all
|
0 / 25 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis bacterial
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis viral
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchopulmonary aspergillosis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Burn infection
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis infective staphylococcal
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COVID-19
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
8 / 4110 (0.19%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
COVID-19 pneumonia
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
7 / 4110 (0.17%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 4 |
Catheter bacteraemia
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter site infection
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
subjects affected / exposed
|
24 / 4101 (0.59%) |
34 / 4110 (0.83%) |
occurrences causally related to treatment / all
|
0 / 27 |
0 / 36 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Chagas' cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cholecystitis infective
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic sinusitis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Citrobacter sepsis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridial infection
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridial sepsis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile infection
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complicated appendicitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Conjunctivitis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dengue fever
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related infection
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Device related sepsis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot infection
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
6 / 4110 (0.15%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gangrene
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea infectious
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Diverticulitis
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eczema infected
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolic pneumonia
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Empyema
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
subjects affected / exposed
|
7 / 4101 (0.17%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Endocarditis bacterial
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Endocarditis enterococcal
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterobacter bacteraemia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterococcal bacteraemia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterococcal infection
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis bacterial
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis viral
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epididymitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
subjects affected / exposed
|
9 / 4101 (0.22%) |
10 / 4110 (0.24%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Escherichia infection
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fournier's gangrene
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fungal infection
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder abscess
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gangrene
|
|
|
subjects affected / exposed
|
8 / 4101 (0.20%) |
5 / 4110 (0.12%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gas gangrene
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
11 / 4101 (0.27%) |
15 / 4110 (0.36%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis bacterial
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis norovirus
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal viral infection
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft infection
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin abscess
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis A
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis viral
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes dermatitis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes virus infection
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implant site infection
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incision site abscess
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected seroma
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected skin ulcer
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection
|
|
|
subjects affected / exposed
|
6 / 4101 (0.15%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Infectious pleural effusion
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective exacerbation of chronic obstructive airways disease
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective myositis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective spondylitis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Influenza
|
|
|
subjects affected / exposed
|
15 / 4101 (0.37%) |
19 / 4110 (0.46%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Intervertebral discitis
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jejunal gangrene
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kidney infection
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Klebsiella bacteraemia
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Klebsiella sepsis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Labyrinthitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine infection
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngitis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver abscess
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Localised infection
|
|
|
subjects affected / exposed
|
6 / 4101 (0.15%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
6 / 4101 (0.15%) |
7 / 4110 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower respiratory tract infection viral
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung abscess
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenitis bacterial
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mediastinitis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device site infection
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis bacterial
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metapneumovirus infection
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myiasis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrotising fasciitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasopharyngitis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ophthalmic herpes zoster
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orchitis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
subjects affected / exposed
|
12 / 4101 (0.29%) |
8 / 4110 (0.19%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Osteomyelitis acute
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis bacterial
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis chronic
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis media bacterial
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parainfluenzae virus infection
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Peritonitis bacterial
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Peritonsillar abscess
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pilonidal cyst
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumococcal sepsis
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pneumonia
|
|
|
subjects affected / exposed
|
179 / 4101 (4.36%) |
171 / 4110 (4.16%) |
occurrences causally related to treatment / all
|
0 / 207 |
0 / 191 |
deaths causally related to treatment / all
|
0 / 20 |
0 / 13 |
Pneumonia adenoviral
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia bacterial
|
|
|
subjects affected / exposed
|
6 / 4101 (0.15%) |
7 / 4110 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia escherichia
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia haemophilus
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia influenzal
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia klebsiella
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia moraxella
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia mycoplasmal
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia necrotising
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pneumonia pneumococcal
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia respiratory syncytial viral
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia staphylococcal
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia viral
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic abscess
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudomembranous colitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary sepsis
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
6 / 4110 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulmonary tuberculosis
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory syncytial virus infection
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
subjects affected / exposed
|
24 / 4101 (0.59%) |
15 / 4110 (0.36%) |
occurrences causally related to treatment / all
|
0 / 28 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Respiratory tract infection bacterial
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection fungal
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection viral
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scrotal abscess
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sepsis
|
|
|
subjects affected / exposed
|
60 / 4101 (1.46%) |
51 / 4110 (1.24%) |
occurrences causally related to treatment / all
|
0 / 61 |
1 / 53 |
deaths causally related to treatment / all
|
0 / 13 |
1 / 16 |
Sepsis syndrome
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Septic shock
|
|
|
subjects affected / exposed
|
32 / 4101 (0.78%) |
37 / 4110 (0.90%) |
occurrences causally related to treatment / all
|
0 / 33 |
0 / 37 |
deaths causally related to treatment / all
|
0 / 10 |
0 / 18 |
Sinusitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinusitis bacterial
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin graft infection
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue infection
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
4 / 4110 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin infection
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal bacteraemia
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal infection
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Staphylococcal sepsis
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sternitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stitch abscess
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcal bacteraemia
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcal endocarditis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth abscess
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheitis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth infection
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheobronchitis
|
|
|
subjects affected / exposed
|
4 / 4101 (0.10%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tuberculoma of central nervous system
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tuberculosis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
subjects affected / exposed
|
11 / 4101 (0.27%) |
14 / 4110 (0.34%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
32 / 4101 (0.78%) |
33 / 4110 (0.80%) |
occurrences causally related to treatment / all
|
0 / 33 |
1 / 39 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Urinary tract infection bacterial
|
|
|
subjects affected / exposed
|
6 / 4101 (0.15%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection enterococcal
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection staphylococcal
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urogenital infection bacterial
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
subjects affected / exposed
|
15 / 4101 (0.37%) |
7 / 4110 (0.17%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Vascular device infection
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viraemia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral infection
|
|
|
subjects affected / exposed
|
3 / 4101 (0.07%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral upper respiratory tract infection
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound abscess
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection bacterial
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection staphylococcal
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound sepsis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Abnormal loss of weight
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acidosis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cachexia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decreased appetite
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dehydration
|
|
|
subjects affected / exposed
|
15 / 4101 (0.37%) |
19 / 4110 (0.46%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Diabetes mellitus
|
|
|
subjects affected / exposed
|
8 / 4101 (0.20%) |
15 / 4110 (0.36%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus inadequate control
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
6 / 4110 (0.15%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
subjects affected / exposed
|
5 / 4101 (0.12%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ketosis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Diabetic metabolic decompensation
|
|
|
subjects affected / exposed
|
8 / 4101 (0.20%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrolyte imbalance
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Failure to thrive
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fluid overload
|
|
|
subjects affected / exposed
|
7 / 4101 (0.17%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fluid retention
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Folate deficiency
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gout
|
|
|
subjects affected / exposed
|
7 / 4101 (0.17%) |
14 / 4110 (0.34%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
11 / 4101 (0.27%) |
9 / 4110 (0.22%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemic hyperosmolar nonketotic syndrome
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
subjects affected / exposed
|
21 / 4101 (0.51%) |
20 / 4110 (0.49%) |
occurrences causally related to treatment / all
|
1 / 23 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hyperosmolar state
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperphosphataemia
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypervolaemia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoalbuminaemia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypocalcaemia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
13 / 4101 (0.32%) |
7 / 4110 (0.17%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
13 / 4101 (0.32%) |
7 / 4110 (0.17%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokalaemic syndrome
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypomagnesaemia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
19 / 4101 (0.46%) |
14 / 4110 (0.34%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypophagia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
3 / 4110 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lactic acidosis
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Latent autoimmune diabetes in adults
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic acidosis
|
|
|
subjects affected / exposed
|
6 / 4101 (0.15%) |
2 / 4110 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic alkalosis
|
|
|
subjects affected / exposed
|
1 / 4101 (0.02%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obesity
|
|
|
subjects affected / exposed
|
2 / 4101 (0.05%) |
0 / 4110 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
subjects affected / exposed
|
0 / 4101 (0.00%) |
1 / 4110 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |