Serious adverse events
|
LCZ696 |
Total subjects affected by serious adverse events
|
|
subjects affected / exposed
|
555 / 1980 (28.03%) |
number of deaths (all causes)
|
186 |
number of deaths resulting from adverse events
|
5 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
Adenocarcinoma of colon
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
B-cell lymphoma
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Basal cell carcinoma
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bladder cancer recurrent
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bladder neoplasm
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bone cancer
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bone cancer metastatic
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Breast cancer
|
|
subjects affected / exposed
|
3 / 1980 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Cholangiocarcinoma
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Colon adenoma
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Colon cancer
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Laryngeal cancer
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Lung adenocarcinoma
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Lung neoplasm
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lung neoplasm malignant
|
|
subjects affected / exposed
|
4 / 1980 (0.20%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
Oesophageal squamous cell carcinoma
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Plasma cell myeloma
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Rectal cancer
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Renal cancer
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Squamous cell carcinoma
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
2 / 3 |
deaths causally related to treatment / all
|
1 / 1 |
Vascular disorders
|
|
Aortic aneurysm
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Aortic embolus
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Circulatory collapse
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Deep vein thrombosis
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Diabetic vascular disorder
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Haematoma
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hypertension
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Hypotension
|
|
subjects affected / exposed
|
18 / 1980 (0.91%) |
occurrences causally related to treatment / all
|
14 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
Leriche syndrome
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Orthostatic hypotension
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Peripheral arterial occlusive disease
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Peripheral artery occlusion
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Peripheral artery stenosis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Peripheral artery thrombosis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Shock
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
General disorders and administration site conditions
|
|
Asthenia
|
|
subjects affected / exposed
|
3 / 1980 (0.15%) |
occurrences causally related to treatment / all
|
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Cardiac death
|
|
subjects affected / exposed
|
4 / 1980 (0.20%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 4 |
Chest discomfort
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Chest pain
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Death
|
|
subjects affected / exposed
|
3 / 1980 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 3 |
General physical health deterioration
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Malaise
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Multiple organ dysfunction syndrome
|
|
subjects affected / exposed
|
7 / 1980 (0.35%) |
occurrences causally related to treatment / all
|
0 / 7 |
deaths causally related to treatment / all
|
0 / 5 |
Non-cardiac chest pain
|
|
subjects affected / exposed
|
4 / 1980 (0.20%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Oedema peripheral
|
|
subjects affected / exposed
|
3 / 1980 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Sudden cardiac death
|
|
subjects affected / exposed
|
15 / 1980 (0.76%) |
occurrences causally related to treatment / all
|
0 / 15 |
deaths causally related to treatment / all
|
0 / 15 |
Sudden death
|
|
subjects affected / exposed
|
13 / 1980 (0.66%) |
occurrences causally related to treatment / all
|
1 / 13 |
deaths causally related to treatment / all
|
1 / 13 |
Social circumstances
|
|
Treatment noncompliance
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Reproductive system and breast disorders
|
|
Acquired hydrocele
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Acquired phimosis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Genital ulceration
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Vaginal haemorrhage
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
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
|
5 / 1980 (0.25%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
Acute respiratory failure
|
|
subjects affected / exposed
|
3 / 1980 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
Asphyxia
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Bronchial oedema
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bronchitis chronic
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bronchospasm
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Chronic obstructive pulmonary disease
|
|
subjects affected / exposed
|
10 / 1980 (0.51%) |
occurrences causally related to treatment / all
|
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
Dyspnoea
|
|
subjects affected / exposed
|
10 / 1980 (0.51%) |
occurrences causally related to treatment / all
|
0 / 13 |
deaths causally related to treatment / all
|
0 / 1 |
Dyspnoea exertional
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Epistaxis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Haemoptysis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hiccups
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hydrothorax
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Pleural effusion
|
|
subjects affected / exposed
|
3 / 1980 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Pleurisy
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pulmonary embolism
|
|
subjects affected / exposed
|
8 / 1980 (0.40%) |
occurrences causally related to treatment / all
|
0 / 9 |
deaths causally related to treatment / all
|
0 / 6 |
Pulmonary fibrosis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pulmonary hypertension
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pulmonary oedema
|
|
subjects affected / exposed
|
8 / 1980 (0.40%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
Respiratory acidosis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Respiratory failure
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
Psychiatric disorders
|
|
Delirium
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Depression
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Disorientation
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Mental disorder
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Product issues
|
|
Device battery issue
|
|
subjects affected / exposed
|
3 / 1980 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Device malfunction
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lead dislodgement
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Investigations
|
|
Arteriogram coronary
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Blood bilirubin increased
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Blood creatinine increased
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Blood potassium decreased
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Blood potassium increased
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Ejection fraction abnormal
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Functional residual capacity decreased
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Hepatic enzyme increased
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
International normalised ratio increased
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Liver function test increased
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Weight decreased
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Injury, poisoning and procedural complications
|
|
Chest injury
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Craniocerebral injury
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Electric shock
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Fall
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Femur fracture
|
|
subjects affected / exposed
|
5 / 1980 (0.25%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Fibula fracture
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Foot fracture
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Fractured skull depressed
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Head injury
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hip fracture
|
|
subjects affected / exposed
|
3 / 1980 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Humerus fracture
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Incisional hernia, obstructive
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Laceration
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Limb injury
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lower limb fracture
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Multiple injuries
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Pelvic fracture
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Procedural haemorrhage
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Respiratory fume inhalation disorder
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Rib fracture
|
|
subjects affected / exposed
|
3 / 1980 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Road traffic accident
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Subarachnoid haemorrhage
|
|
subjects affected / exposed
|
3 / 1980 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
Subdural haematoma
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Subdural haemorrhage
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Tendon rupture
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Thoracic vertebral fracture
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Tibia fracture
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Toxicity to various agents
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Vascular graft occlusion
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Vascular pseudoaneurysm
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Congenital, familial and genetic disorders
|
|
Phimosis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cardiac disorders
|
|
Acute coronary syndrome
|
|
subjects affected / exposed
|
3 / 1980 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
Acute left ventricular failure
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Acute myocardial infarction
|
|
subjects affected / exposed
|
9 / 1980 (0.45%) |
occurrences causally related to treatment / all
|
0 / 10 |
deaths causally related to treatment / all
|
0 / 3 |
Adams-Stokes syndrome
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Angina pectoris
|
|
subjects affected / exposed
|
14 / 1980 (0.71%) |
occurrences causally related to treatment / all
|
1 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
Angina unstable
|
|
subjects affected / exposed
|
10 / 1980 (0.51%) |
occurrences causally related to treatment / all
|
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
Arrhythmia
|
|
subjects affected / exposed
|
4 / 1980 (0.20%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
Atrial fibrillation
|
|
subjects affected / exposed
|
14 / 1980 (0.71%) |
occurrences causally related to treatment / all
|
1 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
Atrioventricular block complete
|
|
subjects affected / exposed
|
5 / 1980 (0.25%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Bradycardia
|
|
subjects affected / exposed
|
3 / 1980 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Cardiac arrest
|
|
subjects affected / exposed
|
13 / 1980 (0.66%) |
occurrences causally related to treatment / all
|
1 / 13 |
deaths causally related to treatment / all
|
1 / 9 |
Cardiac failure
|
|
subjects affected / exposed
|
144 / 1980 (7.27%) |
occurrences causally related to treatment / all
|
2 / 184 |
deaths causally related to treatment / all
|
0 / 35 |
Cardiac failure acute
|
|
subjects affected / exposed
|
21 / 1980 (1.06%) |
occurrences causally related to treatment / all
|
1 / 26 |
deaths causally related to treatment / all
|
1 / 9 |
Cardiac failure chronic
|
|
subjects affected / exposed
|
32 / 1980 (1.62%) |
occurrences causally related to treatment / all
|
0 / 41 |
deaths causally related to treatment / all
|
0 / 5 |
Cardiac failure congestive
|
|
subjects affected / exposed
|
20 / 1980 (1.01%) |
occurrences causally related to treatment / all
|
2 / 26 |
deaths causally related to treatment / all
|
1 / 3 |
Cardio-respiratory arrest
|
|
subjects affected / exposed
|
7 / 1980 (0.35%) |
occurrences causally related to treatment / all
|
0 / 7 |
deaths causally related to treatment / all
|
0 / 7 |
Cardiogenic shock
|
|
subjects affected / exposed
|
8 / 1980 (0.40%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 5 |
Cardiorenal syndrome
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cardiovascular disorder
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Congestive cardiomyopathy
|
|
subjects affected / exposed
|
4 / 1980 (0.20%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
Cor pulmonale
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Coronary artery disease
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Left ventricular dysfunction
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Left ventricular failure
|
|
subjects affected / exposed
|
4 / 1980 (0.20%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
Myocardial infarction
|
|
subjects affected / exposed
|
16 / 1980 (0.81%) |
occurrences causally related to treatment / all
|
0 / 17 |
deaths causally related to treatment / all
|
0 / 9 |
Myocardial ischaemia
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Nodal rhythm
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Palpitations
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Sinus node dysfunction
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Supraventricular tachycardia
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Systolic dysfunction
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ventricular arrhythmia
|
|
subjects affected / exposed
|
5 / 1980 (0.25%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
Ventricular fibrillation
|
|
subjects affected / exposed
|
5 / 1980 (0.25%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Ventricular tachycardia
|
|
subjects affected / exposed
|
31 / 1980 (1.57%) |
occurrences causally related to treatment / all
|
0 / 37 |
deaths causally related to treatment / all
|
0 / 2 |
Nervous system disorders
|
|
Aphasia
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Brain injury
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Brain oedema
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Cerebellar infarction
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Cerebral haemorrhage
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
Cerebral infarction
|
|
subjects affected / exposed
|
6 / 1980 (0.30%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
Cerebral ischaemia
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Cerebrovascular accident
|
|
subjects affected / exposed
|
13 / 1980 (0.66%) |
occurrences causally related to treatment / all
|
0 / 13 |
deaths causally related to treatment / all
|
0 / 4 |
Cervicogenic vertigo
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Coma
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Dementia
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Dizziness
|
|
subjects affected / exposed
|
4 / 1980 (0.20%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Dysarthria
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Epilepsy
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Facial paralysis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Haemorrhagic stroke
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Hemianaesthesia
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hemiparesis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hypoxic-ischaemic encephalopathy
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Ischaemic cerebral infarction
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Ischaemic stroke
|
|
subjects affected / exposed
|
7 / 1980 (0.35%) |
occurrences causally related to treatment / all
|
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
Loss of consciousness
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Post stroke seizure
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Presyncope
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Radiculopathy
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Seizure
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Syncope
|
|
subjects affected / exposed
|
7 / 1980 (0.35%) |
occurrences causally related to treatment / all
|
3 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
Transient ischaemic attack
|
|
subjects affected / exposed
|
4 / 1980 (0.20%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Blood and lymphatic system disorders
|
|
Anaemia
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Normocytic anaemia
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ear and labyrinth disorders
|
|
Vertigo
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Eye disorders
|
|
Cataract
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Open angle glaucoma
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Refraction disorder
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastrointestinal disorders
|
|
Abdominal pain
|
|
subjects affected / exposed
|
9 / 1980 (0.45%) |
occurrences causally related to treatment / all
|
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
Abdominal pain upper
|
|
subjects affected / exposed
|
3 / 1980 (0.15%) |
occurrences causally related to treatment / all
|
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Ascites
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
Constipation
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Diarrhoea
|
|
subjects affected / exposed
|
3 / 1980 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Diverticulum intestinal
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Duodenal ulcer
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Duodenitis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Dyspepsia
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Enteritis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Enterocolitis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastric haemorrhage
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastric ulcer
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastritis
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Gastrointestinal angiodysplasia
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastrointestinal haemorrhage
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Ileus paralytic
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Incarcerated inguinal hernia
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Inguinal hernia
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Intestinal pseudo-obstruction
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Large intestinal obstruction
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Large intestine polyp
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Melaena
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Mesenteric vein thrombosis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Mouth ulceration
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pancreatic mass
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Rectal haemorrhage
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Umbilical hernia
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Vomiting
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hepatobiliary disorders
|
|
Bile duct obstruction
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cholangitis
|
|
subjects affected / exposed
|
3 / 1980 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Cholecystitis
|
|
subjects affected / exposed
|
3 / 1980 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Cholecystitis acute
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cholecystitis chronic
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cholelithiasis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Hepatic cirrhosis
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Hepatic congestion
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hepatic failure
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
Decubitus ulcer
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Diabetic foot
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Renal and urinary disorders
|
|
Acute kidney injury
|
|
subjects affected / exposed
|
18 / 1980 (0.91%) |
occurrences causally related to treatment / all
|
6 / 19 |
deaths causally related to treatment / all
|
0 / 1 |
Chronic kidney disease
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Haematuria
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Leukocyturia
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Nephrolithiasis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Renal failure
|
|
subjects affected / exposed
|
12 / 1980 (0.61%) |
occurrences causally related to treatment / all
|
1 / 13 |
deaths causally related to treatment / all
|
0 / 1 |
Renal impairment
|
|
subjects affected / exposed
|
8 / 1980 (0.40%) |
occurrences causally related to treatment / all
|
1 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
Urethral stenosis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Urinary retention
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Endocrine disorders
|
|
Adrenal insufficiency
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hypothyroidism
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
Arthritis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Back pain
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Joint effusion
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Osteoarthritis
|
|
subjects affected / exposed
|
3 / 1980 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Rheumatic disorder
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Spinal osteoarthritis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Infections and infestations
|
|
Abdominal sepsis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Appendicitis
|
|
subjects affected / exposed
|
3 / 1980 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Arthritis bacterial
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bacteraemia
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bronchitis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bursitis infective
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Campylobacter gastroenteritis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Cellulitis
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Cholecystitis infective
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cystitis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Diabetic foot infection
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Diarrhoea infectious
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Diverticulitis
|
|
subjects affected / exposed
|
3 / 1980 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Ecthyma
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Erysipelas
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Gangrene
|
|
subjects affected / exposed
|
3 / 1980 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
Gastroenteritis
|
|
subjects affected / exposed
|
5 / 1980 (0.25%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Hepatitis E
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hepatitis viral
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Implant site infection
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Infection
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Infectious pleural effusion
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Influenza
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Intervertebral discitis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Localised infection
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lower respiratory tract infection
|
|
subjects affected / exposed
|
4 / 1980 (0.20%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
Lung infection
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Orchitis
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Otitis media chronic
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ovarian abscess
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Peritonitis
|
|
subjects affected / exposed
|
4 / 1980 (0.20%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
Pneumococcal sepsis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pneumonia
|
|
subjects affected / exposed
|
47 / 1980 (2.37%) |
occurrences causally related to treatment / all
|
0 / 48 |
deaths causally related to treatment / all
|
0 / 12 |
Postoperative wound infection
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pyelonephritis acute
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Respiratory tract infection
|
|
subjects affected / exposed
|
3 / 1980 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Sepsis
|
|
subjects affected / exposed
|
12 / 1980 (0.61%) |
occurrences causally related to treatment / all
|
0 / 12 |
deaths causally related to treatment / all
|
0 / 6 |
Sepsis syndrome
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Septic shock
|
|
subjects affected / exposed
|
10 / 1980 (0.51%) |
occurrences causally related to treatment / all
|
0 / 10 |
deaths causally related to treatment / all
|
0 / 6 |
Stoma site infection
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Streptococcal bacteraemia
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Tooth infection
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Tracheobronchitis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Upper respiratory tract infection
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Urinary tract infection
|
|
subjects affected / exposed
|
10 / 1980 (0.51%) |
occurrences causally related to treatment / all
|
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
Urosepsis
|
|
subjects affected / exposed
|
3 / 1980 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
Viral diarrhoea
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Viral infection
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Wound sepsis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Metabolism and nutrition disorders
|
|
Dehydration
|
|
subjects affected / exposed
|
4 / 1980 (0.20%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Diabetes mellitus
|
|
subjects affected / exposed
|
4 / 1980 (0.20%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Diabetes mellitus inadequate control
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Diabetic complication
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Fluid overload
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hyperkalaemia
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Hypoglycaemia
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hyponatraemia
|
|
subjects affected / exposed
|
2 / 1980 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Metabolic acidosis
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Type 2 diabetes mellitus
|
|
subjects affected / exposed
|
1 / 1980 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |