Serious adverse events
|
Finerenone |
Placebo |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
1158 / 3683 (31.44%) |
1215 / 3658 (33.21%) |
number of deaths (all causes)
|
339 |
383 |
number of deaths resulting from adverse events
|
79 |
100 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Acute myeloid leukaemia
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Adenocarcinoma
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma gastric
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal adenoma
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
B-cell lymphoma
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Basal cell carcinoma
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
4 / 3658 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of bladder
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of prostate
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
subjects affected / exposed
|
11 / 3683 (0.30%) |
4 / 3658 (0.11%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer recurrent
|
|
|
subjects affected / exposed
|
3 / 3683 (0.08%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neoplasm
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
3 / 3658 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
subjects affected / exposed
|
3 / 3683 (0.08%) |
3 / 3658 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone cancer
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
4 / 3658 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchial carcinoma
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Cervix carcinoma
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangiocarcinoma
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Chronic lymphocytic leukaemia
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (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
|
1 / 3683 (0.03%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Colon cancer
|
|
|
subjects affected / exposed
|
14 / 3683 (0.38%) |
9 / 3658 (0.25%) |
occurrences causally related to treatment / all
|
1 / 15 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Enchondromatosis
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial cancer
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal carcinoma
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gastric cancer
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glioblastoma
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Haemangioblastoma
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypergammaglobulinaemia benign monoclonal
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypopharyngeal cancer
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
subjects affected / exposed
|
4 / 3683 (0.11%) |
4 / 3658 (0.11%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Laryngeal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphoma
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
3 / 3658 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant pleural effusion
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningioma
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningioma benign
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to bone
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to lung
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastases to liver
|
|
|
subjects affected / exposed
|
3 / 3683 (0.08%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to lymph nodes
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic malignant melanoma
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Myelodysplastic syndrome
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm malignant
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm prostate
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm skin
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal carcinoma
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
5 / 3658 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Oropharyngeal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cancer
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic carcinoma
|
|
|
subjects affected / exposed
|
5 / 3683 (0.14%) |
5 / 3658 (0.14%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Pancreatic carcinoma metastatic
|
|
|
subjects affected / exposed
|
3 / 3683 (0.08%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Papillary thyroid cancer
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papilloma
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pituitary tumour
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (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
|
4 / 3683 (0.11%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Prostate cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Prostate cancer recurrent
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic adenoma
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
3 / 3658 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Respiratory papilloma
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sarcoma
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Seminoma
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (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 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin papilloma
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small cell lung cancer
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Squamous cell carcinoma
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of lung
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of skin
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the oral cavity
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the tongue
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thymoma
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid adenoma
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsil cancer
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transitional cell carcinoma
|
|
|
subjects affected / exposed
|
3 / 3683 (0.08%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine cancer
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon adenoma
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tumour ulceration
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Salivary gland adenoma
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma pancreas
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gastrointestinal cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ear neoplasm malignant
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal neoplasm
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroendocrine carcinoma
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Choroid neoplasm
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Testis cancer
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung neoplasm malignant
|
|
|
subjects affected / exposed
|
7 / 3683 (0.19%) |
8 / 3658 (0.22%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 4 |
Metastases to central nervous system
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pancreatic carcinoma stage IV
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Prostate cancer
|
|
|
subjects affected / exposed
|
10 / 3683 (0.27%) |
24 / 3658 (0.66%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign anorectal neoplasm
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign pancreatic neoplasm
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign gastrointestinal neoplasm
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain neoplasm
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon neoplasm
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Female reproductive neoplasm
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal cancer
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal cancer
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal neoplasm
|
|
|
subjects affected / exposed
|
3 / 3683 (0.08%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ovarian neoplasm
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal neoplasm
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal neoplasm
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic neoplasm
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Lung neoplasm
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
5 / 3658 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Rectal neoplasm
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastasis
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tumour invasion
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid cancer
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma recurrent
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cell carcinoma
|
|
|
subjects affected / exposed
|
3 / 3683 (0.08%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemangioma of spleen
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epithelioid mesothelioma
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hepatic cancer
|
|
|
subjects affected / exposed
|
5 / 3683 (0.14%) |
4 / 3658 (0.11%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 3 |
Hepatocellular carcinoma
|
|
|
subjects affected / exposed
|
3 / 3683 (0.08%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 2 |
Invasive lobular breast carcinoma
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive papillary breast carcinoma
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clear cell renal cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papillary cystadenoma lymphomatosum
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Triple negative breast cancer
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive breast carcinoma
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transitional cell carcinoma recurrent
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papillary renal cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the parotid gland
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Aortic aneurysm
|
|
|
subjects affected / exposed
|
4 / 3683 (0.11%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic dissection
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic stenosis
|
|
|
subjects affected / exposed
|
5 / 3683 (0.14%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortitis
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial thrombosis
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (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
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Essential hypertension
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Giant cell arteritis
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (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 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertension
|
|
|
subjects affected / exposed
|
12 / 3683 (0.33%) |
22 / 3658 (0.60%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
6 / 3658 (0.16%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (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
|
2 / 3683 (0.05%) |
3 / 3658 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
5 / 3658 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral vascular disorder
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phlebitis
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shock
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Subclavian steal syndrome
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systolic hypertension
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose ulceration
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose vein
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vasculitis
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post thrombotic syndrome
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Labile hypertension
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dry gangrene
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
3 / 3683 (0.08%) |
5 / 3658 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery aneurysm
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery occlusion
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
3 / 3658 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive urgency
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
4 / 3658 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extremity necrosis
|
|
|
subjects affected / exposed
|
4 / 3683 (0.11%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral embolism
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic vascular disorder
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (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 / 3683 (0.05%) |
6 / 3658 (0.16%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian artery occlusion
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery aneurysm rupture
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
Abscess drainage
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
3 / 3658 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic aneurysm repair
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve replacement
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicectomy
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula operation
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder calculus removal
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neck resection
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac pacemaker insertion
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid endarterectomy
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystectomy
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
7 / 3658 (0.19%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Circumcision
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery bypass
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Finger amputation
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot amputation
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip arthroplasty
|
|
|
subjects affected / exposed
|
4 / 3683 (0.11%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hysterectomy
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incisional hernia repair
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia repair
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intensive care
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Insertion of ambulatory peritoneal catheter
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Internal fixation of fracture
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Knee arthroplasty
|
|
|
subjects affected / exposed
|
8 / 3683 (0.22%) |
9 / 3658 (0.25%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leg amputation
|
|
|
subjects affected / exposed
|
3 / 3683 (0.08%) |
5 / 3658 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lipoma excision
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung lobectomy
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal polypectomy
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parathyroidectomy
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parotidectomy
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radical hysterectomy
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radioactive iodine therapy
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Removal of foreign body from larynx
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Removal of internal fixation
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cyst excision
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal stone removal
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scar excision
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Roux loop conversion
|
|
|
subjects affected / exposed
|
3 / 3683 (0.08%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin ulcer excision
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal laminectomy
|
|
|
subjects affected / exposed
|
3 / 3683 (0.08%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal decompression
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toe amputation
|
|
|
subjects affected / exposed
|
4 / 3683 (0.11%) |
3 / 3658 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia repair
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transurethral prostatectomy
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
4 / 3658 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine polypectomy
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitrectomy
|
|
|
subjects affected / exposed
|
3 / 3683 (0.08%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implantable defibrillator insertion
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Knee operation
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shoulder arthroplasty
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary revascularisation
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteral stent insertion
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radical prostatectomy
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus management
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Preoperative care
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transurethral bladder resection
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurolysis
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polypectomy
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
3 / 3658 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Caecum operation
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc operation
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
4 / 3658 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery angioplasty
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral nerve decompression
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin neoplasm excision
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Proctocolectomy
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac ablation
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brachytherapy
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb operation
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic surgery
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone operation
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chemotherapy
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colectomy
|
|
|
subjects affected / exposed
|
3 / 3683 (0.08%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye operation
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eyelid operation
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatectomy
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrectomy
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric bypass
|
|
|
subjects affected / exposed
|
3 / 3683 (0.08%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocele operation
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lithotripsy
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal operation
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroidectomy
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth extraction
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose vein operation
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin graft
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal operation
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug therapy
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent insertion
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract operation
|
|
|
subjects affected / exposed
|
7 / 3683 (0.19%) |
3 / 3658 (0.08%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectocele repair
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Percutaneous coronary intervention
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraocular lens implant
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurosurgery
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic stent placement
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery bypass
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestinal polypectomy
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast conserving surgery
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transcatheter aortic valve implantation
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial appendage closure
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic surgery
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cheilectomy
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary catheter removal
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal disorder prophylaxis
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug delivery device placement
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ocular stem cell transplant
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
Asthenia
|
|
|
subjects affected / exposed
|
3 / 3683 (0.08%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest pain
|
|
|
subjects affected / exposed
|
18 / 3683 (0.49%) |
20 / 3658 (0.55%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Death
|
|
|
subjects affected / exposed
|
8 / 3683 (0.22%) |
6 / 3658 (0.16%) |
occurrences causally related to treatment / all
|
0 / 8 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 8 |
1 / 6 |
Generalised oedema
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malaise
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
3 / 3658 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
9 / 3658 (0.25%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
subjects affected / exposed
|
6 / 3683 (0.16%) |
5 / 3658 (0.14%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden death
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Peripheral swelling
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
8 / 3658 (0.22%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Oedema due to cardiac disease
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic inflammatory response syndrome
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Haemorrhagic cyst
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adhesion
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyp
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug intolerance
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
3 / 3658 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complication associated with device
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Hanging
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Immune system disorders
|
|
|
Anaphylactic reaction
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaphylactic shock
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Benign prostatic hyperplasia
|
|
|
subjects affected / exposed
|
12 / 3683 (0.33%) |
10 / 3658 (0.27%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast mass
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast necrosis
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial hyperplasia
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cyst
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Prostatic disorder
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatism
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
3 / 3658 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine polyp
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatomegaly
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Female genital tract fistula
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erectile dysfunction
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scrotal dermatitis
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Acute pulmonary oedema
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
4 / 3658 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute respiratory failure
|
|
|
subjects affected / exposed
|
12 / 3683 (0.33%) |
9 / 3658 (0.25%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 4 |
Asphyxia
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Aspiration
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Asthma
|
|
|
subjects affected / exposed
|
4 / 3683 (0.11%) |
5 / 3658 (0.14%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bronchitis chronic
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
22 / 3683 (0.60%) |
16 / 3658 (0.44%) |
occurrences causally related to treatment / all
|
0 / 24 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Chronic respiratory failure
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cough
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysphonia
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
subjects affected / exposed
|
9 / 3683 (0.24%) |
9 / 3658 (0.25%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea exertional
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
subjects affected / exposed
|
3 / 3683 (0.08%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiccups
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypercapnia
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Idiopathic pulmonary fibrosis
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
4 / 3658 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal oedema
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal septum deviation
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
5 / 3683 (0.14%) |
7 / 3658 (0.19%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pneumonia aspiration
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulmonary congestion
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
4 / 3658 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
6 / 3683 (0.16%) |
11 / 3658 (0.30%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Pulmonary hypertension
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary infarction
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
5 / 3658 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Respiratory acidosis
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory arrest
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Respiratory disorder
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory distress
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
subjects affected / exposed
|
6 / 3683 (0.16%) |
9 / 3658 (0.25%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Sleep apnoea syndrome
|
|
|
subjects affected / exposed
|
5 / 3683 (0.14%) |
4 / 3658 (0.11%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal mass
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary mass
|
|
|
subjects affected / exposed
|
4 / 3683 (0.11%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Laryngeal disorder
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive airways disorder
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthmatic crisis
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchial hyperreactivity
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic hydrothorax
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alveolar lung disease
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung perforation
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small airways disease
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Anxiety
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Confusional state
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delusional disorder, unspecified type
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug abuse
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (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
|
2 / 3683 (0.05%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bipolar disorder
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Major depression
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental disorder due to a general medical condition
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicide threat
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product issues
|
|
|
Device malfunction
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device loosening
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Bile duct stone
|
|
|
subjects affected / exposed
|
5 / 3683 (0.14%) |
3 / 3658 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary colic
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary fistula
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
3 / 3658 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis acute
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
subjects affected / exposed
|
7 / 3683 (0.19%) |
5 / 3658 (0.14%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
subjects affected / exposed
|
9 / 3683 (0.24%) |
7 / 3658 (0.19%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis chronic
|
|
|
subjects affected / exposed
|
3 / 3683 (0.08%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
5 / 3683 (0.14%) |
7 / 3658 (0.19%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic hepatitis
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cirrhosis alcoholic
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fatty liver alcoholic
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hepatic cirrhosis
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatic failure
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatic function abnormal
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis acute
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatorenal syndrome
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Jaundice
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaundice cholestatic
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Liver disorder
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Portal hypertension
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Portal vein thrombosis
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystocholangitis
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder polyp
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-alcoholic steatohepatitis
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary dyskinesia
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Primary biliary cholangitis
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Arthroscopy
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
3 / 3658 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biopsy bladder
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biopsy kidney
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biopsy liver
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biopsy prostate
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatine phosphokinase increased
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
3 / 3658 (0.08%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood glucose increased
|
|
|
subjects affected / exposed
|
4 / 3683 (0.11%) |
4 / 3658 (0.11%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood magnesium decreased
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood potassium decreased
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood potassium increased
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure increased
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
C-reactive protein increased
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colonoscopy
|
|
|
subjects affected / exposed
|
4 / 3683 (0.11%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colonoscopy normal
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Computerised tomogram
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram abnormal
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endoscopy
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glomerular filtration rate decreased
|
|
|
subjects affected / exposed
|
4 / 3683 (0.11%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glycosylated haemoglobin increased
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
3 / 3658 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematocrit decreased
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood urine present
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
International normalised ratio increased
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Weight decreased
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angiogram cerebral
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sleep study
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure orthostatic decreased
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Troponin increased
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac function test abnormal
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anticoagulation drug level below therapeutic
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angiogram
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigation
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory syncytial virus test positive
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza A virus test positive
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
4 / 3658 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endobronchial ultrasound
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver function test increased
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal stoma output increased
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cancer staging
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angiocardiogram
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
SARS-CoV-2 test positive
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (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 test negative
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (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
|
|
|
Accident
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Accidental overdose
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acetabulum fracture
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Animal bite
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
subjects affected / exposed
|
6 / 3683 (0.16%) |
6 / 3658 (0.16%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cartilage injury
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clavicle fracture
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Concussion
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis radiation
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
subjects affected / exposed
|
4 / 3683 (0.11%) |
5 / 3658 (0.14%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Femoral neck fracture
|
|
|
subjects affected / exposed
|
3 / 3683 (0.08%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
subjects affected / exposed
|
8 / 3683 (0.22%) |
8 / 3658 (0.22%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
3 / 3658 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foreign body aspiration
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gun shot wound
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hand fracture
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head injury
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
subjects affected / exposed
|
5 / 3683 (0.14%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
4 / 3658 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury corneal
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple fractures
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Multiple injuries
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Overdose
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Patella fracture
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiation proctitis
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
5 / 3658 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
subjects affected / exposed
|
4 / 3683 (0.11%) |
4 / 3658 (0.11%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Scapula fracture
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skull fractured base
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic injury
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (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
|
3 / 3683 (0.08%) |
6 / 3658 (0.16%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural haemorrhage
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
3 / 3658 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
subjects affected / exposed
|
3 / 3683 (0.08%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
subjects affected / exposed
|
5 / 3683 (0.14%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic ulcer
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulna fracture
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular injury
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia postoperative
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic fracture
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Contusion
|
|
|
subjects affected / exposed
|
4 / 3683 (0.11%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain contusion
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thermal burn
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Intervertebral disc injury
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac procedure complication
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Procedural complication
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin laceration
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint injury
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (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
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pelvic fracture
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb injury
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
3 / 3658 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Poisoning
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Skin injury
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skull fracture
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest injury
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic intracranial haemorrhage
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound complication
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (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
|
2 / 3683 (0.05%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stomal hernia
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular anastomosis aneurysm
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral hyperperfusion syndrome
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin abrasion
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament rupture
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone contusion
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heat illness
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound contamination
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periprosthetic fracture
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Craniocerebral injury
|
|
|
subjects affected / exposed
|
3 / 3683 (0.08%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Procedural haemorrhage
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin wound
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
subjects affected / exposed
|
4 / 3683 (0.11%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye contusion
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural intestinal perforation
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative delirium
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dental restoration failure
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ocular procedural complication
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive tract procedural complication
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (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
|
|
|
Arnold-Chiari malformation
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypospadias
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phimosis
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenomatous polyposis coli
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anomaly of middle ear congenital
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (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 myocardial infarction
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
subjects affected / exposed
|
4 / 3683 (0.11%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve disease mixed
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve incompetence
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve stenosis
|
|
|
subjects affected / exposed
|
3 / 3683 (0.08%) |
3 / 3658 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
subjects affected / exposed
|
4 / 3683 (0.11%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block complete
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block second degree
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
3 / 3683 (0.08%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bundle branch block left
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiac failure
|
|
|
subjects affected / exposed
|
5 / 3683 (0.14%) |
10 / 3658 (0.27%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure acute
|
|
|
subjects affected / exposed
|
4 / 3683 (0.11%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiac failure chronic
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
3 / 3658 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure congestive
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiogenic shock
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cor pulmonale chronic
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
subjects affected / exposed
|
5 / 3683 (0.14%) |
6 / 3658 (0.16%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery occlusion
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
2 / 3658 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extrasystoles
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (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
|
3 / 3683 (0.08%) |
3 / 3658 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Palpitations
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial haemorrhage
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinoatrial block
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular fibrillation
|
|
|
subjects affected / exposed
|
2 / 3683 (0.05%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular tachycardia
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left ventricular hypertrophy
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ventricular hypokinesia
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiopulmonary failure
|
|
|
subjects affected / exposed
|
0 / 3683 (0.00%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Acute coronary syndrome
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
1 / 3658 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulseless electrical activity
|
|
|
subjects affected / exposed
|
1 / 3683 (0.03%) |
0 / 3658 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac valve disease
|
|
|