Serious adverse events
|
Empagliflozin 10 mg |
Placebo |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
765 / 3234 (23.65%) |
798 / 3229 (24.71%) |
number of deaths (all causes)
|
165 |
175 |
number of deaths resulting from adverse events
|
137 |
140 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Brain neoplasm
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute myeloid leukaemia
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
B-cell lymphoma
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of skin
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (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
|
2 / 3234 (0.06%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neoplasm
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain neoplasm malignant
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Keratoacanthoma
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac myxoma
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervix cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cervix carcinoma
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
subjects affected / exposed
|
4 / 3234 (0.12%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Colon neoplasm
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal adenoma
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diffuse large B-cell lymphoma
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial cancer
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Essential thrombocythaemia
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
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
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal carcinoma
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hepatic cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Breast cancer
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine benign neoplasm
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic gastric cancer
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung adenocarcinoma
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung neoplasm malignant
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung squamous cell carcinoma recurrent
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant neoplasm progression
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Mantle cell lymphoma
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Mesothelioma
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastases to liver
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to lung
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to lymph nodes
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (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 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to pleura
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Laryngeal cancer
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic renal cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelodysplastic syndrome
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Neoplasm prostate
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroendocrine carcinoma
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (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
|
0 / 3234 (0.00%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oropharyngeal neoplasm
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Penile squamous cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal cancer
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasmacytoma
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural neoplasm
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
subjects affected / exposed
|
6 / 3234 (0.19%) |
4 / 3229 (0.12%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mucoepidermoid carcinoma
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
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 / 3234 (0.03%) |
4 / 3229 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin cancer
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small cell lung cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Soft tissue neoplasm
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsil cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transitional cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectosigmoid cancer stage III
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Arteriosclerosis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute aortic syndrome
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic aneurysm
|
|
|
subjects affected / exposed
|
3 / 3234 (0.09%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic stenosis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic thrombosis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial thrombosis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure inadequately controlled
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jugular vein thrombosis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
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
|
2 / 3234 (0.06%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extremity necrosis
|
|
|
subjects affected / exposed
|
3 / 3234 (0.09%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral artery embolism
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertension
|
|
|
subjects affected / exposed
|
3 / 3234 (0.09%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
subjects affected / exposed
|
7 / 3234 (0.22%) |
5 / 3229 (0.15%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive urgency
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotension
|
|
|
subjects affected / exposed
|
8 / 3234 (0.25%) |
7 / 3229 (0.22%) |
occurrences causally related to treatment / all
|
0 / 8 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemic shock
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iliac artery arteriosclerosis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intermittent claudication
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery occlusion
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral embolism
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vasoconstriction
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian artery stenosis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian vein stenosis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Superficial vein thrombosis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
subjects affected / exposed
|
3 / 3234 (0.09%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Surgical and medical procedures
|
|
|
Hospitalisation
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
Asthenia
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
4 / 3229 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Vascular stent thrombosis
|
|
|
subjects affected / exposed
|
3 / 3234 (0.09%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest discomfort
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest pain
|
|
|
subjects affected / exposed
|
9 / 3234 (0.28%) |
12 / 3229 (0.37%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Death
|
|
|
subjects affected / exposed
|
21 / 3234 (0.65%) |
21 / 3229 (0.65%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 21 |
0 / 21 |
Gait disturbance
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implant site haematoma
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
28 / 3234 (0.87%) |
27 / 3229 (0.84%) |
occurrences causally related to treatment / all
|
1 / 33 |
0 / 31 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Physical deconditioning
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
subjects affected / exposed
|
4 / 3234 (0.12%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden cardiac death
|
|
|
subjects affected / exposed
|
9 / 3234 (0.28%) |
7 / 3229 (0.22%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 7 |
Sudden death
|
|
|
subjects affected / exposed
|
11 / 3234 (0.34%) |
12 / 3229 (0.37%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 11 |
0 / 12 |
Systemic inflammatory response syndrome
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent stenosis
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac death
|
|
|
subjects affected / exposed
|
3 / 3234 (0.09%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Immune system disorders
|
|
|
Anaphylactic shock
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (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 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Social circumstances
|
|
|
Physical assault
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tobacco user
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Benign prostatic hyperplasia
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Penile scarring
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Epistaxis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute pulmonary oedema
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute respiratory distress syndrome
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute respiratory failure
|
|
|
subjects affected / exposed
|
6 / 3234 (0.19%) |
4 / 3229 (0.12%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Bronchiectasis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
4 / 3234 (0.12%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cough
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
subjects affected / exposed
|
4 / 3234 (0.12%) |
5 / 3229 (0.15%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea exertional
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiccups
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrothorax
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Idiopathic pulmonary fibrosis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Obstructive sleep apnoea syndrome
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oropharyngeal fistula
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
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
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary congestion
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
7 / 3234 (0.22%) |
7 / 3229 (0.22%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary fibrosis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary hypertension
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary mass
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
4 / 3229 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Respiratory failure
|
|
|
subjects affected / exposed
|
5 / 3234 (0.15%) |
5 / 3229 (0.15%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Sleep apnoea syndrome
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Confusional state
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delirium
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mania
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Blood pressure increased
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium test positive
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
International normalised ratio increased
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress echocardiogram abnormal
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
Foot fracture
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal injury
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic injury
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac procedure complication
|
|
|
subjects affected / exposed
|
3 / 3234 (0.09%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cervical vertebral fracture
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Craniofacial fracture
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deep vein thrombosis postoperative
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Face injury
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
5 / 3229 (0.15%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
4 / 3229 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head injury
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Procedural pneumothorax
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb traumatic amputation
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (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 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neck injury
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Overdose
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax traumatic
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
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 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
subjects affected / exposed
|
9 / 3234 (0.28%) |
4 / 3229 (0.12%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural stroke
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative delirium
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sternal fracture
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Strangulated incisional hernia
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical procedure repeated
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (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
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Traumatic haematoma
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
Atrial septal defect
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Buried penis syndrome
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Corneal dystrophy
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Acute coronary syndrome
|
|
|
subjects affected / exposed
|
5 / 3234 (0.15%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute myocardial infarction
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
subjects affected / exposed
|
30 / 3234 (0.93%) |
28 / 3229 (0.87%) |
occurrences causally related to treatment / all
|
0 / 32 |
0 / 29 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
subjects affected / exposed
|
52 / 3234 (1.61%) |
54 / 3229 (1.67%) |
occurrences causally related to treatment / all
|
1 / 57 |
0 / 58 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve stenosis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
subjects affected / exposed
|
3 / 3234 (0.09%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia supraventricular
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmic storm
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
18 / 3234 (0.56%) |
17 / 3229 (0.53%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
subjects affected / exposed
|
6 / 3234 (0.19%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial tachycardia
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial thrombosis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
subjects affected / exposed
|
11 / 3234 (0.34%) |
17 / 3229 (0.53%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 11 |
Atrioventricular block complete
|
|
|
subjects affected / exposed
|
3 / 3234 (0.09%) |
5 / 3229 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradyarrhythmia
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
5 / 3229 (0.15%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac aneurysm
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure
|
|
|
subjects affected / exposed
|
159 / 3234 (4.92%) |
230 / 3229 (7.12%) |
occurrences causally related to treatment / all
|
1 / 194 |
2 / 306 |
deaths causally related to treatment / all
|
0 / 17 |
0 / 23 |
Cardiac perforation
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (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 / 3234 (0.06%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiac ventricular disorder
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac ventricular thrombosis
|
|
|
subjects affected / exposed
|
11 / 3234 (0.34%) |
4 / 3229 (0.12%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
subjects affected / exposed
|
6 / 3234 (0.19%) |
5 / 3229 (0.15%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 4 |
Coronary artery occlusion
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiovascular disorder
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic coronary syndrome
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
subjects affected / exposed
|
14 / 3234 (0.43%) |
14 / 3229 (0.43%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Coronary artery dissection
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery insufficiency
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiogenic shock
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
subjects affected / exposed
|
4 / 3234 (0.12%) |
4 / 3229 (0.12%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery thrombosis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dilated cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dressler's syndrome
|
|
|
subjects affected / exposed
|
3 / 3234 (0.09%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Interventricular septum rupture
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracardiac thrombus
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial rupture
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Microvascular coronary artery disease
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
subjects affected / exposed
|
110 / 3234 (3.40%) |
94 / 3229 (2.91%) |
occurrences causally related to treatment / all
|
0 / 119 |
0 / 104 |
deaths causally related to treatment / all
|
0 / 20 |
0 / 10 |
Myocardial injury
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial ischaemia
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
6 / 3229 (0.19%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic cardiomyopathy
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nodal rhythm
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricle rupture
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Papillary muscle rupture
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pericardial effusion
|
|
|
subjects affected / exposed
|
4 / 3234 (0.12%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial haemorrhage
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pericarditis
|
|
|
subjects affected / exposed
|
3 / 3234 (0.09%) |
4 / 3229 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postinfarction angina
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prinzmetal angina
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus arrest
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus node dysfunction
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
3 / 3234 (0.09%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Palpitations
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular arrhythmia
|
|
|
subjects affected / exposed
|
3 / 3234 (0.09%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ventricular extrasystoles
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular fibrillation
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular flutter
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular tachycardia
|
|
|
subjects affected / exposed
|
18 / 3234 (0.56%) |
22 / 3229 (0.68%) |
occurrences causally related to treatment / all
|
0 / 29 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Nervous system disorders
|
|
|
Cerebral hypoperfusion
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aphasia
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ataxia
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
subjects affected / exposed
|
4 / 3234 (0.12%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery thrombosis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral infarction
|
|
|
subjects affected / exposed
|
6 / 3234 (0.19%) |
4 / 3229 (0.12%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral ischaemia
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
subjects affected / exposed
|
8 / 3234 (0.25%) |
8 / 3229 (0.25%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Cortical laminar necrosis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia Alzheimer's type
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracranial mass
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial paralysis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic stroke
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Headache
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness
|
|
|
subjects affected / exposed
|
4 / 3234 (0.12%) |
5 / 3229 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
subjects affected / exposed
|
7 / 3234 (0.22%) |
11 / 3229 (0.34%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Syncope
|
|
|
subjects affected / exposed
|
16 / 3234 (0.49%) |
19 / 3229 (0.59%) |
occurrences causally related to treatment / all
|
2 / 18 |
1 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lumbar radiculopathy
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorder
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraesthesia
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peroneal nerve palsy
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
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 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Presyncope
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiculopathy
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ruptured cerebral aneurysm
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Seizure
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Status epilepticus
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lacunar infarction
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular encephalopathy
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral artery occlusion
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebrobasilar insufficiency
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebrobasilar stroke
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tremor
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (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
|
9 / 3234 (0.28%) |
11 / 3229 (0.34%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Microcytic anaemia
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytosis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemolysis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
Sudden hearing loss
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo
|
|
|
subjects affected / exposed
|
3 / 3234 (0.09%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Optic ischaemic neuropathy
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular hole
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic retinopathy
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular degeneration
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal artery embolism
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal infarction
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vision blurred
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual impairment
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Abdominal discomfort
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall haematoma
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
subjects affected / exposed
|
3 / 3234 (0.09%) |
5 / 3229 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal polyp
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Food poisoning
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (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
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal angiodysplasia
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
28 / 3234 (0.87%) |
22 / 3229 (0.68%) |
occurrences causally related to treatment / all
|
1 / 29 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Gastrointestinal necrosis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus paralytic
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
subjects affected / exposed
|
3 / 3234 (0.09%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal angina
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal metaplasia
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Irritable bowel syndrome
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
subjects affected / exposed
|
3 / 3234 (0.09%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melaena
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (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
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nausea
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal stenosis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oronasal fistula
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
subjects affected / exposed
|
3 / 3234 (0.09%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis chronic
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic floor hernia
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (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
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal polyp
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Volvulus
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric vein thrombosis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Cholecystitis
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cholangitis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholestasis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic cholecystitis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cirrhosis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic hepatitis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver injury
|
|
|
subjects affected / exposed
|
6 / 3234 (0.19%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Portal vein thrombosis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (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
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary obstruction
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Angioedema
|
|
|
subjects affected / exposed
|
4 / 3234 (0.12%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis allergic
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
Chronic kidney disease
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
4 / 3229 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute kidney injury
|
|
|
subjects affected / exposed
|
27 / 3234 (0.83%) |
43 / 3229 (1.33%) |
occurrences causally related to treatment / all
|
6 / 32 |
8 / 51 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 4 |
Bladder disorder
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
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
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureterolithiasis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematuria
|
|
|
subjects affected / exposed
|
5 / 3234 (0.15%) |
10 / 3229 (0.31%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephritis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephropathy toxic
|
|
|
subjects affected / exposed
|
6 / 3234 (0.19%) |
9 / 3229 (0.28%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oliguria
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyuria
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal colic
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal haematoma
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
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
|
1 / 3234 (0.03%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal infarct
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysuria
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary bladder polyp
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
4 / 3229 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Arthritis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neck pain
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondrocalcinosis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc disorder
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
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
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myalgia
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back pain
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oligoarthritis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polymyalgia rheumatica
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
subjects affected / exposed
|
3 / 3234 (0.09%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Abdominal abscess
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronavirus infection
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
subjects affected / exposed
|
5 / 3234 (0.15%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Arthritis bacterial
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis infective
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
COVID-19
|
|
|
subjects affected / exposed
|
20 / 3234 (0.62%) |
25 / 3229 (0.77%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 4 |
COVID-19 pneumonia
|
|
|
subjects affected / exposed
|
14 / 3234 (0.43%) |
10 / 3229 (0.31%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 3 |
Campylobacter gastroenteritis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridial infection
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile infection
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Colonic abscess
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complicated appendicitis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronavirus pneumonia
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dental fistula
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
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
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gangrene
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea infectious
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
subjects affected / exposed
|
3 / 3234 (0.09%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endotoxic shock
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis infectious
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis bacterial
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epididymitis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (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
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Fungal infection
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perineal infection
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gangrene
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis aeromonas
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected fistula
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint abscess
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
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
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenic sepsis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Norovirus infection
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
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 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fungal skin infection
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SARS-CoV-2 viraemia
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
subjects affected / exposed
|
9 / 3234 (0.28%) |
8 / 3229 (0.25%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Sepsis
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
3 / 3229 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Septic shock
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
6 / 3229 (0.19%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 4 |
Staphylococcal bacteraemia
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Tooth abscess
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
9 / 3234 (0.28%) |
7 / 3229 (0.22%) |
occurrences causally related to treatment / all
|
3 / 9 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
subjects affected / exposed
|
31 / 3234 (0.96%) |
30 / 3229 (0.93%) |
occurrences causally related to treatment / all
|
0 / 31 |
0 / 33 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 3 |
Postoperative wound infection
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal abscess
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salmonellosis
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral infection
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular neuronitis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Hypovolaemia
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cell death
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Decreased appetite
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dehydration
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
4 / 3229 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus inadequate control
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic metabolic decompensation
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
subjects affected / exposed
|
3 / 3234 (0.09%) |
6 / 3229 (0.19%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypocalcaemia
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
3 / 3234 (0.09%) |
2 / 3229 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iron deficiency
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ketoacidosis
|
|
|
subjects affected / exposed
|
2 / 3234 (0.06%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic acidosis
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
0 / 3229 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polydipsia
|
|
|
subjects affected / exposed
|
0 / 3234 (0.00%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 1 diabetes mellitus
|
|
|
subjects affected / exposed
|
1 / 3234 (0.03%) |
1 / 3229 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |