Serious adverse events
|
Cohort A: Tafamidis (Parent and Extension Study) |
Cohort B: Tafamidis (Only in extension study) |
Cohort A: Placebo (Parent Study)/Tafamidis (Extension Study) |
Total subjects affected by serious adverse events
|
|
|
|
subjects affected / exposed
|
132 / 170 (77.65%) |
736 / 1476 (49.86%) |
64 / 82 (78.05%) |
number of deaths (all causes)
|
45 |
203 |
33 |
number of deaths resulting from adverse events
|
40 |
198 |
32 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
Adenocarcinoma of colon
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
4 / 1476 (0.27%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adrenal neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal squamous cell carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
B-cell lymphoma
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Basal cell carcinoma
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
9 / 1476 (0.61%) |
2 / 82 (2.44%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 10 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
1 / 1476 (0.07%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma recurrent
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bowen's disease
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cancer pain
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Central nervous system melanoma
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic myelomonocytic leukaemia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colon neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diffuse large B-cell lymphoma
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hormone-dependent prostate cancer
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast cancer
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung neoplasm malignant
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to lung
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myelodysplastic syndrome with excess blasts
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neuroendocrine carcinoma metastatic
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Neuroendocrine tumour
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-small cell lung cancer stage IIIB
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal squamous cell carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oncocytoma
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Primary pulmonary melanoma
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
|
subjects affected / exposed
|
3 / 170 (1.76%) |
5 / 1476 (0.34%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer metastatic
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
1 / 1476 (0.07%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Renal neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
6 / 1476 (0.41%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of skin
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transitional cell carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
4 / 1476 (0.27%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
Distributive shock
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
Bleeding varicose vein
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Axillary vein thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriovenous fistula
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic stenosis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
10 / 1476 (0.68%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 11 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic dissection
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Embolism
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematoma
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Extremity necrosis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Embolism venous
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive urgency
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypotension
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
16 / 1476 (1.08%) |
4 / 82 (4.88%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 16 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Peripheral venous disease
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Shock
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
Iliac artery stenosis
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic limb pain
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic venous thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery occlusion
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Peripheral artery stenosis
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral embolism
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral vein stenosis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Shock haemorrhagic
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subclavian vein thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Venous thrombosis limb
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
|
Therapy change
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac ablation
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Implantable defibrillator insertion
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Muscle electrostimulation therapy
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound treatment
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
Asthenia
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
5 / 1476 (0.34%) |
2 / 82 (2.44%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Chest pain
|
|
|
|
subjects affected / exposed
|
4 / 170 (2.35%) |
5 / 1476 (0.34%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Death
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
7 / 1476 (0.47%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 7 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
7 / 7 |
1 / 1 |
Discomfort
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Inflammation
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fatigue
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
11 / 1476 (0.75%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 13 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 1 |
Generalised oedema
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Hernia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypothermia
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Implant site haematoma
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Disease progression
|
|
|
|
subjects affected / exposed
|
4 / 170 (2.35%) |
22 / 1476 (1.49%) |
3 / 82 (3.66%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 22 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 22 |
0 / 3 |
Multi-organ disorder
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
Non-cardiac chest pain
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
6 / 1476 (0.41%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 9 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pain
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral swelling
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sudden death
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
6 / 1476 (0.41%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
6 / 6 |
0 / 0 |
Systemic inflammatory response syndrome
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
Acquired ATTR amyloidosis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Amyloidosis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Anaphylactic reaction
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Graft versus host disease
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Primary amyloidosis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
Breast pain
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatomegaly
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Scrotal swelling
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign prostatic hyperplasia
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
5 / 1476 (0.34%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
Atelectasis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute respiratory distress syndrome
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute respiratory failure
|
|
|
|
subjects affected / exposed
|
3 / 170 (1.76%) |
7 / 1476 (0.47%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
Dyspnoea exertional
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
2 / 82 (2.44%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
5 / 1476 (0.34%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Hypercapnia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Interstitial lung disease
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
|
subjects affected / exposed
|
3 / 170 (1.76%) |
13 / 1476 (0.88%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 13 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
|
subjects affected / exposed
|
3 / 170 (1.76%) |
10 / 1476 (0.68%) |
4 / 82 (4.88%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 11 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonitis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary alveolar haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Cough
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Organising pneumonia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary amyloidosis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
4 / 1476 (0.27%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary fibrosis
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary hypertension
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary infarction
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary toxicity
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory disorder
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory distress
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Respiratory failure
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
12 / 1476 (0.81%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 13 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
Pulmonary oedema
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
7 / 1476 (0.47%) |
2 / 82 (2.44%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Psychiatric disorders
|
|
|
|
Agitation
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anxiety
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Confusional state
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
6 / 1476 (0.41%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Depressed mood
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hallucination
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Major depression
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
4 / 1476 (0.27%) |
2 / 82 (2.44%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mixed anxiety and depressive disorder
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Suicidal ideation
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Delirium
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Product issues
|
|
|
|
Device loosening
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device capturing issue
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device dislocation
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device failure
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device inappropriate shock delivery
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device malfunction
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device occlusion
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
Biliary colic
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac cirrhosis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
5 / 1476 (0.34%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Congestive hepatopathy
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
1 / 1476 (0.07%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic cirrhosis
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Hepatic failure
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Hepatic function abnormal
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis acute
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatomegaly
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic hepatitis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Jaundice
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Investigations
|
|
|
|
Blood potassium abnormal
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Activated partial thromboplastin time prolonged
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anticoagulation drug level above therapeutic
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Apnoea test
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood bilirubin increased
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood urea increased
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial aspiration procedure
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ejection fraction
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ejection fraction decreased
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemoglobin decreased
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Heart rate irregular
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peritoneal fluid analysis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
SARS-CoV-2 test positive
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
4 / 1476 (0.27%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Troponin increased
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
International normalised ratio increased
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
Chest injury
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clavicle fracture
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Complications of transplanted kidney
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervical vertebral fracture
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acetabulum fracture
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac procedure complication
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Contusion
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Craniofacial fracture
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fall
|
|
|
|
subjects affected / exposed
|
10 / 170 (5.88%) |
25 / 1476 (1.69%) |
5 / 82 (6.10%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 26 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Fat embolism
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Femoral neck fracture
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
2 / 1476 (0.14%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Head injury
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
3 / 1476 (0.20%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Hip fracture
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
9 / 1476 (0.61%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 10 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Humerus fracture
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ilium fracture
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Injury
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
4 / 1476 (0.27%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Limb injury
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Muscle strain
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nasal injury
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Overdose
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Pelvic fracture
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
4 / 1476 (0.27%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Periprosthetic fracture
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Periprosthetic osteolysis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural constipation
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haematuria
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Procedural complication
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Procedural pneumothorax
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary contusion
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
4 / 1476 (0.27%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Seroma
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin abrasion
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin laceration
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
|
subjects affected / exposed
|
3 / 170 (1.76%) |
1 / 1476 (0.07%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Splenic injury
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Splenic rupture
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sternal fracture
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
10 / 1476 (0.68%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 15 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Tendon rupture
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Traumatic intracranial haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract stoma complication
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vasoplegia syndrome
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Wound haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound secretion
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
|
Familial amyloidosis
|
|
|
|
subjects affected / exposed
|
4 / 170 (2.35%) |
10 / 1476 (0.68%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 10 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 1 |
Hereditary neuropathic amyloidosis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
Acute coronary syndrome
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute left ventricular failure
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
7 / 1476 (0.47%) |
3 / 82 (3.66%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bradyarrhythmia
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bifascicular block
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block complete
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
16 / 1476 (1.08%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 16 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
|
subjects affected / exposed
|
4 / 170 (2.35%) |
8 / 1476 (0.54%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrial tachycardia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
4 / 1476 (0.27%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
|
subjects affected / exposed
|
4 / 170 (2.35%) |
18 / 1476 (1.22%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 18 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
|
subjects affected / exposed
|
11 / 170 (6.47%) |
62 / 1476 (4.20%) |
8 / 82 (9.76%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 79 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
Arrhythmia supraventricular
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
|
subjects affected / exposed
|
3 / 170 (1.76%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve stenosis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
11 / 1476 (0.75%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 12 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
11 / 1476 (0.75%) |
2 / 82 (2.44%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 11 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute myocardial infarction
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
7 / 1476 (0.47%) |
2 / 82 (2.44%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Bundle branch block bilateral
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiomyopathy
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Cardiogenic shock
|
|
|
|
subjects affected / exposed
|
3 / 170 (1.76%) |
20 / 1476 (1.36%) |
2 / 82 (2.44%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 22 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 9 |
0 / 0 |
Cardio-respiratory distress
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Cardiac flutter
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure congestive
|
|
|
|
subjects affected / exposed
|
17 / 170 (10.00%) |
52 / 1476 (3.52%) |
14 / 82 (17.07%) |
occurrences causally related to treatment / all
|
0 / 24 |
0 / 60 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 6 |
0 / 6 |
Cardiac failure chronic
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
10 / 1476 (0.68%) |
4 / 82 (4.88%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 12 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 0 |
Cardiac failure acute
|
|
|
|
subjects affected / exposed
|
13 / 170 (7.65%) |
48 / 1476 (3.25%) |
10 / 82 (12.20%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 60 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 1 |
Cardiac failure
|
|
|
|
subjects affected / exposed
|
30 / 170 (17.65%) |
169 / 1476 (11.45%) |
17 / 82 (20.73%) |
occurrences causally related to treatment / all
|
0 / 55 |
1 / 255 |
0 / 30 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 33 |
0 / 6 |
Cardiac arrest
|
|
|
|
subjects affected / exposed
|
6 / 170 (3.53%) |
14 / 1476 (0.95%) |
3 / 82 (3.66%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 14 |
0 / 3 |
deaths causally related to treatment / all
|
1 / 2 |
0 / 13 |
0 / 2 |
Cardiac amyloidosis
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
16 / 1476 (1.08%) |
2 / 82 (2.44%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 17 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 12 |
0 / 2 |
Bundle branch block right
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bundle branch block left
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
4 / 1476 (0.27%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Low cardiac output syndrome
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Left ventricular failure
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
6 / 1476 (0.41%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Left ventricular dysfunction
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial ischaemia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Conduction disorder
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
5 / 1476 (0.34%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic left ventricular failure
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
3 / 1476 (0.20%) |
3 / 82 (3.66%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
Cardiovascular insufficiency
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Cardiorenal syndrome
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Cardiopulmonary failure
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
2 / 82 (2.44%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery embolism
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinoatrial block
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinus arrest
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinus node dysfunction
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
10 / 1476 (0.68%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 10 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
7 / 1476 (0.47%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 7 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Nodal arrhythmia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nodal rhythm
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Palpitations
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Paroxysmal atrioventricular block
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
|
subjects affected / exposed
|
3 / 170 (1.76%) |
2 / 1476 (0.14%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Restrictive cardiomyopathy
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Right ventricular dysfunction
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Right ventricular failure
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tachyarrhythmia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Torsade de pointes
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tricuspid valve incompetence
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular arrhythmia
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular dysfunction
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
4 / 1476 (0.27%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular tachycardia
|
|
|
|
subjects affected / exposed
|
3 / 170 (1.76%) |
17 / 1476 (1.15%) |
6 / 82 (7.32%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 18 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
Ventricular fibrillation
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Nervous system disorders
|
|
|
|
Cerebral ischaemia
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Brain compression
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain injury
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral artery embolism
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Cerebral infarction
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ataxia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrospinal fluid leakage
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
17 / 1476 (1.15%) |
3 / 82 (3.66%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 17 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervical radiculopathy
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cognitive disorder
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
6 / 1476 (0.41%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Coma
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Dementia
|
|
|
|
subjects affected / exposed
|
3 / 170 (1.76%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Headache
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dysarthria
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Embolic stroke
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
|
subjects affected / exposed
|
3 / 170 (1.76%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Haemorrhagic transformation stroke
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dizziness
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
5 / 1476 (0.34%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neuralgia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Peripheral sensorimotor neuropathy
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Polyneuropathy
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lethargy
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Radiculopathy
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hemianopia
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hemianopia homonymous
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic encephalopathy
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Ischaemic cerebral infarction
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
11 / 1476 (0.75%) |
3 / 82 (3.66%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 12 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
Presyncope
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
4 / 1476 (0.27%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Seizure
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Somnolence
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Syncope
|
|
|
|
subjects affected / exposed
|
6 / 170 (3.53%) |
42 / 1476 (2.85%) |
2 / 82 (2.44%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 43 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transient global amnesia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
9 / 1476 (0.61%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 10 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Vascular dementia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular encephalopathy
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uraemic encephalopathy
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
Anaemia
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
17 / 1476 (1.15%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 24 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spontaneous haematoma
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Normochromic normocytic anaemia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Immune thrombocytopenia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Deficiency anaemia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coagulopathy
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood loss anaemia
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aplastic anaemia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Iron deficiency anaemia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
|
Meniere's disease
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
Amaurosis fugax
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blindness unilateral
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cataract
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Charles Bonnet syndrome
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Optic ischaemic neuropathy
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Orbital haematoma
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vitreous haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vision blurred
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
Abdominal pain upper
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal adhesions
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal discomfort
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal distension
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
6 / 1476 (0.41%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain lower
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute abdomen
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Appendiceal mucocoele
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ascites
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
8 / 1476 (0.54%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 10 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic gastritis
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colitis microscopic
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
4 / 170 (2.35%) |
13 / 1476 (0.88%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 15 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Faecaloma
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Constipation
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
2 / 1476 (0.14%) |
2 / 82 (2.44%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal ulcer haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal vascular malformation haemorrhagic
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ileus
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Impaired gastric emptying
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Incarcerated umbilical hernia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
4 / 1476 (0.27%) |
2 / 82 (2.44%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia strangulated
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal ischaemia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Intestinal obstruction
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
3 / 1476 (0.20%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intra-abdominal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated inguinal hernia
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumoperitoneum
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Portal hypertensive gastropathy
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
|
subjects affected / exposed
|
3 / 170 (1.76%) |
7 / 1476 (0.47%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
4 / 1476 (0.27%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Melaena
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
4 / 1476 (0.27%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mesenteric vascular insufficiency
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nausea
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
3 / 1476 (0.20%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal motility disorder
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal ulcer
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
6 / 1476 (0.41%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 7 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vomiting
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
4 / 1476 (0.27%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
Cellulite
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Actinic keratosis
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin necrosis
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rash papular
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rash maculo-papular
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pruritus
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperhidrosis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Decubitus ulcer
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Stasis dermatitis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eczema
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
Acute kidney injury
|
|
|
|
subjects affected / exposed
|
16 / 170 (9.41%) |
34 / 1476 (2.30%) |
13 / 82 (15.85%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 42 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 1 |
Chronic kidney disease
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
7 / 1476 (0.47%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 8 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
End stage renal disease
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
Glomerulonephritis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematuria
|
|
|
|
subjects affected / exposed
|
3 / 170 (1.76%) |
8 / 1476 (0.54%) |
3 / 82 (3.66%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 12 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage urinary tract
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal failure
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
5 / 1476 (0.34%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
Nephrolithiasis
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
1 / 1476 (0.07%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nephrotic syndrome
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Polyuria
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal disorder
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
7 / 1476 (0.47%) |
2 / 82 (2.44%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Renal pseudoaneurysm
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ureteric obstruction
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ureterolithiasis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
|
subjects affected / exposed
|
3 / 170 (1.76%) |
7 / 1476 (0.47%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
|
Hyperthyroidism
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
Arthralgia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
9 / 1476 (0.61%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 9 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Back pain
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
4 / 1476 (0.27%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Immunoglobulin G4 related disease
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dupuytren's contracture
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gouty arthritis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Greater trochanteric pain syndrome
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemarthrosis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematoma muscle
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chondrocalcinosis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
4 / 1476 (0.27%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Muscle spasms
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
9 / 1476 (0.61%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 10 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tenosynovitis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pathological fracture
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rheumatoid arthritis
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal stenosis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
4 / 1476 (0.27%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tendonitis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
Appendicitis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis infective
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
4 / 1476 (0.27%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Bacterial pyelonephritis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Beta haemolytic streptococcal infection
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Bronchitis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device related infection
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bursitis infective
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
COVID-19
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
16 / 1476 (1.08%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 16 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
COVID-19 pneumonia
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
9 / 1476 (0.61%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 9 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Cardiac infection
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
subjects affected / exposed
|
8 / 170 (4.71%) |
18 / 1476 (1.22%) |
5 / 82 (6.10%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 20 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis staphylococcal
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis viral
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulitis intestinal perforated
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endophthalmitis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
4 / 1476 (0.27%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
Escherichia sepsis
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Extradural abscess
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Diverticulitis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
5 / 1476 (0.34%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal viral infection
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematoma infection
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis A
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster meningoencephalitis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic foot infection
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster meningomyelitis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Implant site infection
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infection
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infectious pleural effusion
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infective exacerbation of chronic obstructive airways disease
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Influenza
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
2 / 1476 (0.14%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Localised infection
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meningitis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meningitis bacterial
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Necrotising fasciitis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Oesophageal candidiasis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Legionella infection
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pericarditis infective
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Peritonsillar abscess
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
|
subjects affected / exposed
|
12 / 170 (7.06%) |
39 / 1476 (2.64%) |
9 / 82 (10.98%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 49 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 3 |
Pneumonia aspiration
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
5 / 1476 (0.34%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
Pneumonia bacterial
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
Pseudomonal sepsis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Pneumonia pneumococcal
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia staphylococcal
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia streptococcal
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia viral
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural sepsis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia klebsiella
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary sepsis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Pyelonephritis
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory moniliasis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
7 / 1476 (0.47%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 7 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection bacterial
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Scrotal cellulitis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Streptococcal bacteraemia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Septic shock
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
10 / 1476 (0.68%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 10 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 0 |
Sialoadenitis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spontaneous bacterial peritonitis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal bacteraemia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
3 / 1476 (0.20%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Staphylococcal infection
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sepsis
|
|
|
|
subjects affected / exposed
|
8 / 170 (4.71%) |
17 / 1476 (1.15%) |
4 / 82 (4.88%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 17 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 1 |
Streptococcal sepsis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Superinfection fungal
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Tracheobronchitis
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
17 / 1476 (1.15%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 17 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Urosepsis
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
5 / 1476 (0.34%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular device infection
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Viral infection
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
Diabetes mellitus
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cachexia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Decreased appetite
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dehydration
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
7 / 1476 (0.47%) |
5 / 82 (6.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic metabolic decompensation
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Electrolyte imbalance
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
0 / 1476 (0.00%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Failure to thrive
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
4 / 1476 (0.27%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
Fluid retention
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gout
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
9 / 1476 (0.61%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 9 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
|
subjects affected / exposed
|
3 / 170 (1.76%) |
4 / 1476 (0.27%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
8 / 1476 (0.54%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypernatraemia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypervolaemia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
8 / 1476 (0.54%) |
2 / 82 (2.44%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 9 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
|
subjects affected / exposed
|
2 / 170 (1.18%) |
9 / 1476 (0.61%) |
2 / 82 (2.44%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 9 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperglycaemic hyperosmolar nonketotic syndrome
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
2 / 1476 (0.14%) |
1 / 82 (1.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
|
subjects affected / exposed
|
0 / 170 (0.00%) |
1 / 1476 (0.07%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolic alkalosis
|
|
|
|
subjects affected / exposed
|
1 / 170 (0.59%) |
0 / 1476 (0.00%) |
0 / 82 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |