Serious adverse events
|
HZ/su Group |
Total subjects affected by serious adverse events
|
|
subjects affected / exposed
|
734 / 8687 (8.45%) |
number of deaths (all causes)
|
107 |
number of deaths resulting from adverse events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
Acoustic neuroma
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Acute myeloid leukaemia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Adenocarcinoma of colon
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Adenocarcinoma pancreas
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
B precursor type acute leukaemia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Basal cell carcinoma
|
|
subjects affected / exposed
|
6 / 8687 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
Benign lung neoplasm
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bladder cancer
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bladder neoplasm
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bladder transitional cell carcinoma
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Brain neoplasm
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Breast cancer
|
|
subjects affected / exposed
|
12 / 8687 (0.14%) |
occurrences causally related to treatment / all
|
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
Cancer pain
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cardiac myxoma
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cholangiocarcinoma
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Chronic lymphocytic leukaemia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Chronic myeloid leukaemia
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Colon adenoma
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Colon cancer
|
|
subjects affected / exposed
|
4 / 8687 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
Colon cancer metastatic
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Colon neoplasm
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Colorectal cancer
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Endometrial adenocarcinoma
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Ganglioneuroma
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastric cancer
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Gastric neoplasm
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Gastrointestinal carcinoma
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastrointestinal neoplasm
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Glioblastoma
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Glioblastoma multiforme
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Hepatocellular carcinoma
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Hodgkin’s disease
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hypopharyngeal neoplasm
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Insulinoma
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Invasive breast carcinoma
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Invasive ductal breast carcinoma
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Large intestine benign neoplasm
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Laryngeal cancer
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lip neoplasm malignant stage unspecified
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lung adenocarcinoma
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Lung neoplasm malignant
|
|
subjects affected / exposed
|
8 / 8687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 4 |
Malignant melanoma in situ
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Marginal zone lymphoma
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Metastases to lung
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Metastatic malignant melanoma
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Metastatic neoplasm
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Oesophageal carcinoma
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ovarian cancer
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Ovarian cancer recurrent
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pancreatic carcinoma
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Penile cancer
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Plasma cell myeloma
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Prostate cancer
|
|
subjects affected / exposed
|
9 / 8687 (0.10%) |
occurrences causally related to treatment / all
|
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
Rectal adenocarcinoma
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Rectal neoplasm
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Renal cancer
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
Renal cell carcinoma recurrent
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Salivary gland neoplasm
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Small cell lung cancer
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Squamous cell carcinoma
|
|
subjects affected / exposed
|
4 / 8687 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Squamous cell carcinoma of lung
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Squamous cell carcinoma of skin
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Transitional cell carcinoma
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
Uterine cancer
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Vascular disorders
|
|
Aortic aneurysm
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Aortic dissection
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Aortic rupture
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Aortic stenosis
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Arterial rupture
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Arteriosclerosis
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Deep vein thrombosis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Embolism venous
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Extremity necrosis
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Haematoma
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hypertension
|
|
subjects affected / exposed
|
10 / 8687 (0.12%) |
occurrences causally related to treatment / all
|
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
Hypertensive crisis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hypovolaemic shock
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Intermittent claudication
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Peripheral arterial occlusive disease
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Peripheral venous disease
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Phlebitis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Poor peripheral circulation
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Shock haemorrhagic
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Subclavian steal syndrome
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Temporal arteritis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Thrombosis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
General disorders and administration site conditions
|
|
Accidental death
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Adverse drug reaction
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Chest discomfort
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Chest pain
|
|
subjects affected / exposed
|
8 / 8687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
Death
|
|
subjects affected / exposed
|
6 / 8687 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 6 |
General physical health deterioration
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
Multiple organ dysfunction syndrome
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 3 |
Oedema
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Oedema peripheral
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Pyrexia
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Sudden death
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Vascular stent stenosis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Vascular stent thrombosis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Immune system disorders
|
|
Anaphylactic reaction
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Drug hypersensitivity
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hypersensitivity
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Reproductive system and breast disorders
|
|
Benign prostatic hyperplasia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Breast pain
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cystocele
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Erectile dysfunction
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Menorrhagia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ovarian cyst
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Prostatitis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Rectocele
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
Acute pulmonary oedema
|
|
subjects affected / exposed
|
4 / 8687 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
Acute respiratory distress syndrome
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Acute respiratory failure
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Asthma
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Atelectasis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Chronic obstructive pulmonary disease
|
|
subjects affected / exposed
|
8 / 8687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 2 |
Dyspnoea
|
|
subjects affected / exposed
|
4 / 8687 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
Haemoptysis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Haemothorax
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Interstitial lung disease
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Lung disorder
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pleural effusion
|
|
subjects affected / exposed
|
6 / 8687 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 3 |
Pneumonia aspiration
|
|
subjects affected / exposed
|
5 / 8687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Pneumothorax
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
Pneumothorax spontaneous
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pulmonary embolism
|
|
subjects affected / exposed
|
8 / 8687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
Pulmonary haemorrhage
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pulmonary hypertension
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Pulmonary oedema
|
|
subjects affected / exposed
|
5 / 8687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
Respiratory distress
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Respiratory failure
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Sinus perforation
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Psychiatric disorders
|
|
Confusional state
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Depression
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Psychotic disorder
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Investigations
|
|
Blood potassium decreased
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Blood pressure increased
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Injury, poisoning and procedural complications
|
|
Acetabulum fracture
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Alcohol poisoning
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Anaemia postoperative
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ankle fracture
|
|
subjects affected / exposed
|
4 / 8687 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Cardiac valve rupture
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Chest injury
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Concussion
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Contusion
|
|
subjects affected / exposed
|
4 / 8687 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Craniocerebral injury
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Facial bones fracture
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Femoral neck fracture
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Fall
|
|
subjects affected / exposed
|
5 / 8687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Femur fracture
|
|
subjects affected / exposed
|
8 / 8687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
Head injury
|
|
subjects affected / exposed
|
6 / 8687 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 2 |
Hip fracture
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Humerus fracture
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Jaw fracture
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Joint injury
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Kidney contusion
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ligament rupture
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Limb injury
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Liver contusion
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lower limb fracture
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lumbar vertebral fracture
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Multiple fractures
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Multiple injuries
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Patella fracture
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Periprosthetic fracture
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Poisoning
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Post procedural complication
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Post procedural haematoma
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Post procedural swelling
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pulmonary contusion
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Radiation proctitis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Radius fracture
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Rib fracture
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Road traffic accident
|
|
subjects affected / exposed
|
5 / 8687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
Seroma
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Shunt occlusion
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Skin injury
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Skin laceration
|
|
subjects affected / exposed
|
5 / 8687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Spinal column injury
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Spinal compression fracture
|
|
subjects affected / exposed
|
5 / 8687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Subdural haematoma
|
|
subjects affected / exposed
|
7 / 8687 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
Tendon rupture
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Tibia fracture
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Transfusion-related acute lung injury
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Traumatic liver injury
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ulnar nerve injury
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Upper limb fracture
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Vascular pseudoaneurysm
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Viith nerve injury
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Wound dehiscence
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Wrist fracture
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Congenital, familial and genetic disorders
|
|
Left ventricle outflow tract obstruction
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Type v hyperlipidaemia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cardiac disorders
|
|
Acute coronary syndrome
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Acute myocardial infarction
|
|
subjects affected / exposed
|
18 / 8687 (0.21%) |
occurrences causally related to treatment / all
|
0 / 19 |
deaths causally related to treatment / all
|
0 / 2 |
Angina pectoris
|
|
subjects affected / exposed
|
12 / 8687 (0.14%) |
occurrences causally related to treatment / all
|
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
Aortic valve stenosis
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Arrhythmia
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Arteriosclerosis coronary artery
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Atrial fibrillation
|
|
subjects affected / exposed
|
25 / 8687 (0.29%) |
occurrences causally related to treatment / all
|
0 / 27 |
deaths causally related to treatment / all
|
0 / 2 |
Atrial flutter
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Atrial tachycardia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Atrioventricular block
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Atrioventricular block complete
|
|
subjects affected / exposed
|
4 / 8687 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Atrioventricular block second degree
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Bradyarrhythmia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bradycardia
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Cardiac arrest
|
|
subjects affected / exposed
|
8 / 8687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 8 |
Cardiac failure
|
|
subjects affected / exposed
|
28 / 8687 (0.32%) |
occurrences causally related to treatment / all
|
0 / 32 |
deaths causally related to treatment / all
|
0 / 17 |
Cardiac failure acute
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Cardiac failure chronic
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cardiac failure congestive
|
|
subjects affected / exposed
|
14 / 8687 (0.16%) |
occurrences causally related to treatment / all
|
0 / 14 |
deaths causally related to treatment / all
|
0 / 7 |
Cardiac ventricular thrombosis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cardio-respiratory arrest
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Cardiogenic shock
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Cardiomegaly
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cor pulmonale
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Coronary artery disease
|
|
subjects affected / exposed
|
9 / 8687 (0.10%) |
occurrences causally related to treatment / all
|
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
Coronary artery stenosis
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Hypertensive heart disease
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Ischaemic cardiomyopathy
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Mitral valve incompetence
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Mitral valve stenosis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Myocardial infarction
|
|
subjects affected / exposed
|
18 / 8687 (0.21%) |
occurrences causally related to treatment / all
|
0 / 18 |
deaths causally related to treatment / all
|
0 / 7 |
Myocardial ischaemia
|
|
subjects affected / exposed
|
8 / 8687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
Myocarditis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Nodal rhythm
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Parasystole
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pericardial effusion
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Pericarditis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Prinzmetal angina
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Sinus node dysfunction
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Supraventricular tachycardia
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Tachyarrhythmia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Tachycardia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Ventricular tachycardia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Nervous system disorders
|
|
Basal ganglia haemorrhage
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Carotid artery stenosis
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Carotid sinus syndrome
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cerebellar ataxia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cerebellar infarction
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Cerebral haemorrhage
|
|
subjects affected / exposed
|
4 / 8687 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 3 |
Cerebral infarction
|
|
subjects affected / exposed
|
8 / 8687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
Cerebral ischaemia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cerebrovascular accident
|
|
subjects affected / exposed
|
14 / 8687 (0.16%) |
occurrences causally related to treatment / all
|
0 / 14 |
deaths causally related to treatment / all
|
0 / 3 |
Coma
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Dizziness
|
|
subjects affected / exposed
|
4 / 8687 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Embolic cerebral infarction
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Epilepsy
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Facial paralysis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Haemorrhage intracranial
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Haemorrhagic stroke
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Haemorrhagic transformation stroke
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Headache
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hemiparesis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ischaemic stroke
|
|
subjects affected / exposed
|
4 / 8687 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Lacunar stroke
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Loss of consciousness
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Myoclonus
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Neuroglycopenia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Normal pressure hydrocephalus
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Petit mal epilepsy
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Presyncope
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Radicular pain
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Sciatica
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Subarachnoid haemorrhage
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Syncope
|
|
subjects affected / exposed
|
8 / 8687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
Transient global amnesia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Transient ischaemic attack
|
|
subjects affected / exposed
|
11 / 8687 (0.13%) |
occurrences causally related to treatment / all
|
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
Vith nerve paralysis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Senile dementia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Seizure
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Blood and lymphatic system disorders
|
|
Anaemia
|
|
subjects affected / exposed
|
5 / 8687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
Febrile neutropenia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Immune thrombocytopenic purpura
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Leukocytosis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ear and labyrinth disorders
|
|
Acute vestibular syndrome
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Vertigo
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Vertigo positional
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Eye disorders
|
|
Cataract
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cataract nuclear
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Diplopia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Macular hole
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Retinal artery occlusion
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Retinal detachment
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Gastrointestinal disorders
|
|
Abdominal distension
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Abdominal pain upper
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ascites
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Chronic gastritis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Colitis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Colitis ischaemic
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Colitis ulcerative
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Constipation
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Diarrhoea
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Diverticular perforation
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Diverticulum
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Diverticulum intestinal
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Duodenal ulcer
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastric ulcer
|
|
subjects affected / exposed
|
7 / 8687 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
Gastritis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastrointestinal haemorrhage
|
|
subjects affected / exposed
|
8 / 8687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
Gastrointestinal inflammation
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastrooesophageal reflux disease
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Haematochezia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Haemorrhoids
|
|
subjects affected / exposed
|
4 / 8687 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Hiatus hernia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ileus
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Incarcerated umbilical hernia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Inguinal hernia
|
|
subjects affected / exposed
|
8 / 8687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
Intestinal obstruction
|
|
subjects affected / exposed
|
5 / 8687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
Large intestinal obstruction
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Large intestine polyp
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Mallory-weiss syndrome
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Melaena
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Mouth haemorrhage
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Mouth ulceration
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Nausea
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Obstructive pancreatitis
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Oesophageal perforation
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Pancreatitis
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Pancreatitis acute
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pancreatitis chronic
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Peritoneal haemorrhage
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Small intestinal obstruction
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Spigelian hernia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Tooth impacted
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
Volvulus
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Vomiting
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hepatobiliary disorders
|
|
Bile duct stone
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Cholangitis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Cholecystitis
|
|
subjects affected / exposed
|
5 / 8687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Cholecystitis acute
|
|
subjects affected / exposed
|
4 / 8687 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Cholelithiasis
|
|
subjects affected / exposed
|
5 / 8687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Hepatic cirrhosis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hepatic haematoma
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Jaundice
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
Diabetic foot
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Eczema
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Psoriasis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Rash pruritic
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Skin ulcer
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Urticaria
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Renal and urinary disorders
|
|
Acute kidney injury
|
|
subjects affected / exposed
|
6 / 8687 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
Bladder obstruction
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Chronic kidney disease
|
|
subjects affected / exposed
|
6 / 8687 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 4 |
End stage renal disease
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Glomerulonephritis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Haematuria
|
|
subjects affected / exposed
|
4 / 8687 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Hydronephrosis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Nephrolithiasis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Prerenal failure
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Renal failure
|
|
subjects affected / exposed
|
4 / 8687 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
Renal impairment
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Renal injury
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Tubulointerstitial nephritis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Urethral stenosis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ureterolithiasis
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Endocrine disorders
|
|
Goitre
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Toxic goitre
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
Arthralgia
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Arthritis
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Back pain
|
|
subjects affected / exposed
|
6 / 8687 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
Gouty arthritis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Haemarthrosis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Intervertebral disc compression
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Intervertebral disc degeneration
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Intervertebral disc protrusion
|
|
subjects affected / exposed
|
4 / 8687 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Joint effusion
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lumbar spinal stenosis
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Musculoskeletal chest pain
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Osteoarthritis
|
|
subjects affected / exposed
|
15 / 8687 (0.17%) |
occurrences causally related to treatment / all
|
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
Osteolysis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Osteoporosis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Periarthritis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Rhabdomyolysis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Rotator cuff syndrome
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Spinal osteoarthritis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Spinal stenosis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Spondylolisthesis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Tendonitis
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Tenosynovitis stenosans
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Infections and infestations
|
|
Abdominal abscess
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Abscess
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Abscess limb
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Appendicitis
|
|
subjects affected / exposed
|
5 / 8687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Appendicitis perforated
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Arthritis bacterial
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Atypical pneumonia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bacterial infection
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Bone tuberculosis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bronchitis
|
|
subjects affected / exposed
|
6 / 8687 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
Cellulitis
|
|
subjects affected / exposed
|
8 / 8687 (0.09%) |
occurrences causally related to treatment / all
|
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
Clostridium difficile colitis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cytomegalovirus colitis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Diabetic foot infection
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Diverticulitis
|
|
subjects affected / exposed
|
7 / 8687 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
Endophthalmitis
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Erysipelas
|
|
subjects affected / exposed
|
4 / 8687 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Escherichia bacteraemia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Escherichia infection
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Escherichia pyelonephritis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastric ulcer helicobacter
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastroenteritis
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Herpes simplex
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Infection
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Infectious pleural effusion
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Influenza
|
|
subjects affected / exposed
|
9 / 8687 (0.10%) |
occurrences causally related to treatment / all
|
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
Joint abscess
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Liver abscess
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Localised infection
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lower respiratory tract infection
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
Necrotising fasciitis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Osteomyelitis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Otitis externa
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Paraoesophageal abscess
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pathogen resistance
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Peritonitis
|
|
subjects affected / exposed
|
4 / 8687 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Peritonsillar abscess
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pilonidal cyst
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pneumonia
|
|
subjects affected / exposed
|
54 / 8687 (0.62%) |
occurrences causally related to treatment / all
|
0 / 58 |
deaths causally related to treatment / all
|
0 / 4 |
Pneumonia haemophilus
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pneumonia viral
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Postoperative wound infection
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pyelonephritis
|
|
subjects affected / exposed
|
4 / 8687 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Respiratory tract infection
|
|
subjects affected / exposed
|
4 / 8687 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
Respiratory tract infection bacterial
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Sepsis
|
|
subjects affected / exposed
|
10 / 8687 (0.12%) |
occurrences causally related to treatment / all
|
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
Septic shock
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
Systemic candida
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Tooth abscess
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Upper respiratory tract infection
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Urinary tract infection
|
|
subjects affected / exposed
|
17 / 8687 (0.20%) |
occurrences causally related to treatment / all
|
0 / 17 |
deaths causally related to treatment / all
|
0 / 1 |
Urosepsis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Vulval abscess
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Sinusitis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Metabolism and nutrition disorders
|
|
Dehydration
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Diabetes mellitus inadequate control
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Gout
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Hyperglycaemia
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Hypoglycaemia
|
|
subjects affected / exposed
|
4 / 8687 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Hypokalaemia
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hyponatraemia
|
|
subjects affected / exposed
|
5 / 8687 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Latent autoimmune diabetes in adults
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Metabolic acidosis
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Tumour lysis syndrome
|
|
subjects affected / exposed
|
1 / 8687 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Type 1 diabetes mellitus
|
|
subjects affected / exposed
|
2 / 8687 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Type 2 diabetes mellitus
|
|
subjects affected / exposed
|
3 / 8687 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |