Serious adverse events
|
Abiraterone Acetate |
Total subjects affected by serious adverse events
|
|
subjects affected / exposed
|
818 / 2316 (35.32%) |
number of deaths (all causes)
|
248 |
number of deaths resulting from adverse events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
Cancer Pain
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Basal Cell Carcinoma
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Carcinoid Tumour of the Caecum
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastric Cancer
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Colon Cancer
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Lung Adenocarcinoma
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lung Neoplasm Malignant
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Malignant Melanoma
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Malignant Pleural Effusion
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Meningeal Neoplasm
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Metastases to Bone Marrow
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Metastases to Bone
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Metastases to Central Nervous System
|
|
subjects affected / exposed
|
6 / 2316 (0.26%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
Metastases to Lung
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Metastases to Liver
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Metastatic Pain
|
|
subjects affected / exposed
|
3 / 2316 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
Metastases to Meninges
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Neoplasm Malignant
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
Pancreatic Carcinoma
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Pancreatic Neoplasm
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Prostate Cancer
|
|
subjects affected / exposed
|
5 / 2316 (0.22%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 4 |
Prostate Cancer Metastatic
|
|
subjects affected / exposed
|
3 / 2316 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 3 |
Rectal Cancer
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Tumour Flare
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Tumour Pain
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Vascular disorders
|
|
Arterial Occlusive Disease
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Circulatory Collapse
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
Deep Vein Thrombosis
|
|
subjects affected / exposed
|
8 / 2316 (0.35%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
Haematoma
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Haemorrhage
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Hypertension
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hypotension
|
|
subjects affected / exposed
|
8 / 2316 (0.35%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 2 |
Peripheral Ischaemia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Vascular Compression
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Shock
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Venous Thrombosis Limb
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Surgical and medical procedures
|
|
Aortic Valve Replacement
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Coronary Angioplasty
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Fasciectomy
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hernia Repair
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hospitalisation
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Photon Radiation Therapy to Brain
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lung Lobectomy
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Radiotherapy
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Spinal Decompression
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Spinal Fusion Surgery
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Stent Removal
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
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
|
15 / 2316 (0.65%) |
occurrences causally related to treatment / all
|
0 / 15 |
deaths causally related to treatment / all
|
0 / 4 |
Chest Discomfort
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Chest Pain
|
|
subjects affected / exposed
|
5 / 2316 (0.22%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
Death
|
|
subjects affected / exposed
|
12 / 2316 (0.52%) |
occurrences causally related to treatment / all
|
0 / 12 |
deaths causally related to treatment / all
|
0 / 12 |
Device Failure
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Discomfort
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Disease Progression
|
|
subjects affected / exposed
|
25 / 2316 (1.08%) |
occurrences causally related to treatment / all
|
0 / 25 |
deaths causally related to treatment / all
|
0 / 22 |
Drug Interaction
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Fatigue
|
|
subjects affected / exposed
|
15 / 2316 (0.65%) |
occurrences causally related to treatment / all
|
0 / 16 |
deaths causally related to treatment / all
|
0 / 4 |
General Physical Health Deterioration
|
|
subjects affected / exposed
|
39 / 2316 (1.68%) |
occurrences causally related to treatment / all
|
0 / 40 |
deaths causally related to treatment / all
|
0 / 31 |
Hernia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hyperpyrexia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Malaise
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Multi-Organ Failure
|
|
subjects affected / exposed
|
9 / 2316 (0.39%) |
occurrences causally related to treatment / all
|
0 / 9 |
deaths causally related to treatment / all
|
0 / 9 |
Medical Device Complication
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Non-Cardiac Chest Pain
|
|
subjects affected / exposed
|
5 / 2316 (0.22%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Oedema
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Oedema Peripheral
|
|
subjects affected / exposed
|
10 / 2316 (0.43%) |
occurrences causally related to treatment / all
|
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
Pain
|
|
subjects affected / exposed
|
20 / 2316 (0.86%) |
occurrences causally related to treatment / all
|
0 / 22 |
deaths causally related to treatment / all
|
0 / 1 |
Performance Status Decreased
|
|
subjects affected / exposed
|
6 / 2316 (0.26%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 6 |
Sudden Death
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
Pyrexia
|
|
subjects affected / exposed
|
21 / 2316 (0.91%) |
occurrences causally related to treatment / all
|
0 / 29 |
deaths causally related to treatment / all
|
0 / 0 |
Reproductive system and breast disorders
|
|
Breast Pain
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Prostatic Obstruction
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
Acute Interstitial Pneumonitis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Acute Respiratory Failure
|
|
subjects affected / exposed
|
3 / 2316 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 3 |
Chronic Obstructive Pulmonary Disease
|
|
subjects affected / exposed
|
3 / 2316 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
Cough
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Dyspnoea
|
|
subjects affected / exposed
|
15 / 2316 (0.65%) |
occurrences causally related to treatment / all
|
0 / 17 |
deaths causally related to treatment / all
|
0 / 2 |
Epistaxis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Haemoptysis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Interstitial Lung Disease
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hydrothorax
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Laryngeal Oedema
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lung Disorder
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Pleural Effusion
|
|
subjects affected / exposed
|
9 / 2316 (0.39%) |
occurrences causally related to treatment / all
|
0 / 10 |
deaths causally related to treatment / all
|
0 / 1 |
Pneumonia Aspiration
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Pneumonitis
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Pneumothorax
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Pulmonary Congestion
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pulmonary Embolism
|
|
subjects affected / exposed
|
12 / 2316 (0.52%) |
occurrences causally related to treatment / all
|
0 / 12 |
deaths causally related to treatment / all
|
0 / 2 |
Pulmonary Microemboli
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pulmonary Oedema
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Respiratory Arrest
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
Respiratory Disorder
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Respiratory Failure
|
|
subjects affected / exposed
|
10 / 2316 (0.43%) |
occurrences causally related to treatment / all
|
0 / 10 |
deaths causally related to treatment / all
|
0 / 10 |
Psychiatric disorders
|
|
Agitation
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Confusional State
|
|
subjects affected / exposed
|
3 / 2316 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Delirium
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Depression
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Disorientation
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Mental Status Changes
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hallucination
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Suicidal Ideation
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Suicide Attempt
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Investigations
|
|
Biopsy Liver
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Blood Creatinine Increased
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Haemoglobin Decreased
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hepatic Enzyme Increased
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
International Normalised Ratio Increased
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Liver Function Test Abnormal
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Platelet Count Decreased
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Prostatic Specific Antigen Increased
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Urine Output Decreased
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Injury, poisoning and procedural complications
|
|
Accident
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Accidental Overdose
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
Ankle Fracture
|
|
subjects affected / exposed
|
3 / 2316 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Clavicle Fracture
|
|
subjects affected / exposed
|
4 / 2316 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
Cervical Vertebral Fracture
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Compression Fracture
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cystitis Radiation
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Fall
|
|
subjects affected / exposed
|
5 / 2316 (0.22%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
Femoral Neck Fracture
|
|
subjects affected / exposed
|
4 / 2316 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Femur Fracture
|
|
subjects affected / exposed
|
5 / 2316 (0.22%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
Foot Fracture
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Fracture
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hand Fracture
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Head Injury
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Humerus Fracture
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lumbar Vertebral Fracture
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Open Wound
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Overdose
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Patella Fracture
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pelvic Fracture
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Post Procedural Haematuria
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Rib Fracture
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Radius Fracture
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Spinal Compression Fracture
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Spinal Fracture
|
|
subjects affected / exposed
|
5 / 2316 (0.22%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Subdural Haematoma
|
|
subjects affected / exposed
|
5 / 2316 (0.22%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
Subdural Haemorrhage
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Thoracic Vertebral Fracture
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Toxicity to Various Agents
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Transfusion Reaction
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Traumatic Brain Injury
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Upper Limb Fracture
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Wound Secretion
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cardiac disorders
|
|
Acute Coronary Syndrome
|
|
subjects affected / exposed
|
5 / 2316 (0.22%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 3 |
Acute Myocardial Infarction
|
|
subjects affected / exposed
|
6 / 2316 (0.26%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
Angina Pectoris
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Angina Unstable
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Arrhythmia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Atrial Fibrillation
|
|
subjects affected / exposed
|
8 / 2316 (0.35%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
Atrial Flutter
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Atrioventricular Block
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bundle Branch Block Left
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cardiac Arrest
|
|
subjects affected / exposed
|
8 / 2316 (0.35%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 8 |
Cardiac Disorder
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cardiac Failure
|
|
subjects affected / exposed
|
9 / 2316 (0.39%) |
occurrences causally related to treatment / all
|
0 / 9 |
deaths causally related to treatment / all
|
0 / 4 |
Cardiac Failure Congestive
|
|
subjects affected / exposed
|
6 / 2316 (0.26%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 4 |
Cardio-Respiratory Arrest
|
|
subjects affected / exposed
|
4 / 2316 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 4 |
Cardio-Respiratory Distress
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Cardiovascular Disorder
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Myocardial Infarction
|
|
subjects affected / exposed
|
6 / 2316 (0.26%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
Intracardiac Thrombus
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Myocardial Ischaemia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Palpitations
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pericardial Effusion
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Supraventricular Tachycardia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Tachycardia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ventricular Tachycardia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Nervous system disorders
|
|
Altered State of Consciousness
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Brain Oedema
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Central Nervous System Lesion
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Cerebral Haemorrhage
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
Cerebral Infarction
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Cerebral Ischaemia
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Cerebrovascular Accident
|
|
subjects affected / exposed
|
5 / 2316 (0.22%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 5 |
Cognitive Disorder
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Coma
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Convulsion
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cranial Nerve Disorder
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Depressed Level of Consciousness
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Diabetic Coma
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Diabetic Neuropathy
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Dizziness
|
|
subjects affected / exposed
|
3 / 2316 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
Dysarthria
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Encephalopathy
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Epilepsy
|
|
subjects affected / exposed
|
3 / 2316 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Haemorrhage Intracranial
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Hemiparesis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Headache
|
|
subjects affected / exposed
|
4 / 2316 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Hemiplegia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Iiird Nerve Paralysis
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Lethargy
|
|
subjects affected / exposed
|
4 / 2316 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
Loss of Consciousness
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Metabolic Encephalopathy
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Nerve Root Compression
|
|
subjects affected / exposed
|
4 / 2316 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Monoparesis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Neuralgia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Neurological Symptom
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Paraparesis
|
|
subjects affected / exposed
|
5 / 2316 (0.22%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
Paraplegia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Peripheral Sensory Neuropathy
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Presyncope
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Sedation
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Sciatica
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Spinal Cord Compression
|
|
subjects affected / exposed
|
28 / 2316 (1.21%) |
occurrences causally related to treatment / all
|
0 / 28 |
deaths causally related to treatment / all
|
0 / 2 |
Syncope
|
|
subjects affected / exposed
|
4 / 2316 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Trigeminal Neuralgia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Transient Ischaemic Attack
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Blood and lymphatic system disorders
|
|
Anaemia
|
|
alternative assessment type: Systematic
|
|
subjects affected / exposed
|
50 / 2316 (2.16%) |
occurrences causally related to treatment / all
|
0 / 53 |
deaths causally related to treatment / all
|
0 / 12 |
Anaemia Macrocytic
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bone Marrow Failure
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Disseminated Intravascular Coagulation
|
|
subjects affected / exposed
|
4 / 2316 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 3 |
Febrile Neutropenia
|
|
subjects affected / exposed
|
4 / 2316 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
Leukopenia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lymphadenopathy
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Neutropenia
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Pancytopenia
|
|
subjects affected / exposed
|
3 / 2316 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
Thrombocytopenia
|
|
subjects affected / exposed
|
8 / 2316 (0.35%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
Thrombotic Thrombocytopenic Purpura
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Ear and labyrinth disorders
|
|
Vertigo Positional
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Vertigo
|
|
subjects affected / exposed
|
3 / 2316 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Eye disorders
|
|
Glaucoma
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Diplopia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Visual Impairment
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Retinal Vein Occlusion
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastrointestinal disorders
|
|
Abdominal Adhesions
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Abdominal Distension
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Abdominal Mass
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Abdominal Pain
|
|
subjects affected / exposed
|
9 / 2316 (0.39%) |
occurrences causally related to treatment / all
|
0 / 10 |
deaths causally related to treatment / all
|
0 / 1 |
Abdominal Pain Upper
|
|
subjects affected / exposed
|
5 / 2316 (0.22%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Anal Fistula
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Anal Haemorrhage
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ascites
|
|
subjects affected / exposed
|
3 / 2316 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
Colonic Obstruction
|
|
subjects affected / exposed
|
3 / 2316 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
Colitis
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Constipation
|
|
subjects affected / exposed
|
7 / 2316 (0.30%) |
occurrences causally related to treatment / all
|
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
Diarrhoea
|
|
subjects affected / exposed
|
11 / 2316 (0.47%) |
occurrences causally related to treatment / all
|
0 / 11 |
deaths causally related to treatment / all
|
0 / 1 |
Diverticulum
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Diverticulum Intestinal Haemorrhagic
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Duodenal Ulcer
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Dysphagia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Erosive Oesophagitis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Enterovesical Fistula
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastritis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastrointestinal Hypomotility
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastrointestinal Haemorrhage
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
Haematemesis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gingivitis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hiatus Hernia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ileus
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Impaired Gastric Emptying
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Intestinal Obstruction
|
|
subjects affected / exposed
|
7 / 2316 (0.30%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
Large Intestine Perforation
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Lower Gastrointestinal Haemorrhage
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Nausea
|
|
subjects affected / exposed
|
7 / 2316 (0.30%) |
occurrences causally related to treatment / all
|
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
Mouth Haemorrhage
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Proctalgia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pancreatitis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Obstruction Gastric
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Rectal Haemorrhage
|
|
subjects affected / exposed
|
6 / 2316 (0.26%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
Retroperitoneal Haemorrhage
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Vomiting
|
|
subjects affected / exposed
|
13 / 2316 (0.56%) |
occurrences causally related to treatment / all
|
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
Small Intestinal Obstruction
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Upper Gastrointestinal Haemorrhage
|
|
subjects affected / exposed
|
3 / 2316 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
Hepatobiliary disorders
|
|
Cholangitis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cholecystitis Acute
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Cholecystitis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hepatic Function Abnormal
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hepatic Failure
|
|
subjects affected / exposed
|
6 / 2316 (0.26%) |
occurrences causally related to treatment / all
|
0 / 6 |
deaths causally related to treatment / all
|
0 / 4 |
Hepatitis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hepatorenal Failure
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Hyperbilirubinaemia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Liver Injury
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Renal and urinary disorders
|
|
Bladder Obstruction
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Dysuria
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Bladder Spasm
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Haematuria
|
|
subjects affected / exposed
|
30 / 2316 (1.30%) |
occurrences causally related to treatment / all
|
0 / 41 |
deaths causally related to treatment / all
|
0 / 2 |
Hydronephrosis
|
|
subjects affected / exposed
|
10 / 2316 (0.43%) |
occurrences causally related to treatment / all
|
0 / 10 |
deaths causally related to treatment / all
|
0 / 1 |
Nephrolithiasis
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Nephropathy Toxic
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Obstructive Uropathy
|
|
subjects affected / exposed
|
3 / 2316 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Renal Failure
|
|
subjects affected / exposed
|
7 / 2316 (0.30%) |
occurrences causally related to treatment / all
|
0 / 7 |
deaths causally related to treatment / all
|
0 / 2 |
Renal Impairment
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Renal Failure Acute
|
|
subjects affected / exposed
|
16 / 2316 (0.69%) |
occurrences causally related to treatment / all
|
0 / 16 |
deaths causally related to treatment / all
|
0 / 5 |
Ureteric Rupture
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Urethral Stenosis
|
|
subjects affected / exposed
|
3 / 2316 (0.13%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Urinary Incontinence
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Urinary Retention
|
|
subjects affected / exposed
|
12 / 2316 (0.52%) |
occurrences causally related to treatment / all
|
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
Urinary Tract Obstruction
|
|
subjects affected / exposed
|
5 / 2316 (0.22%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Endocrine disorders
|
|
Adrenal Insufficiency
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
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
|
13 / 2316 (0.56%) |
occurrences causally related to treatment / all
|
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
Back Pain
|
|
subjects affected / exposed
|
52 / 2316 (2.25%) |
occurrences causally related to treatment / all
|
0 / 58 |
deaths causally related to treatment / all
|
0 / 3 |
Bone Pain
|
|
subjects affected / exposed
|
16 / 2316 (0.69%) |
occurrences causally related to treatment / all
|
0 / 16 |
deaths causally related to treatment / all
|
0 / 3 |
Bursitis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Groin Pain
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Haemarthrosis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lumbar Spinal Stenosis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Muscle Spasms
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Muscular Weakness
|
|
subjects affected / exposed
|
7 / 2316 (0.30%) |
occurrences causally related to treatment / all
|
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
Musculoskeletal Chest Pain
|
|
subjects affected / exposed
|
4 / 2316 (0.17%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Musculoskeletal Pain
|
|
subjects affected / exposed
|
8 / 2316 (0.35%) |
occurrences causally related to treatment / all
|
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
Myalgia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Neck Pain
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Osteoarthritis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Osteonecrosis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Osteonecrosis of Jaw
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pain in Extremity
|
|
subjects affected / exposed
|
7 / 2316 (0.30%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
Pathological Fracture
|
|
subjects affected / exposed
|
3 / 2316 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
Rhabdomyolysis
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Infections and infestations
|
|
Abdominal Infection
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Abscess Limb
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Anal Abscess
|
|
subjects affected / exposed
|
3 / 2316 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
Alveolar Osteitis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Appendicitis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Arteriovenous Fistula Site Infection
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Arthritis Infective
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bacteraemia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Bacterial Infection
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Biliary Tract Infection
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Biliary Sepsis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Bronchitis
|
|
subjects affected / exposed
|
4 / 2316 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
Cellulitis
|
|
subjects affected / exposed
|
3 / 2316 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Bronchopneumonia
|
|
subjects affected / exposed
|
3 / 2316 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Clostridium Difficile Colitis
|
|
subjects affected / exposed
|
3 / 2316 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Cellulitis Orbital
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Cystitis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Device Related Infection
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Diverticulitis
|
|
subjects affected / exposed
|
3 / 2316 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Enterocolitis Infectious
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Escherichia Bacteraemia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Escherichia Sepsis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Eye Infection
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastroenteritis
|
|
subjects affected / exposed
|
4 / 2316 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
Gastrointestinal Infection
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Gastroenteritis Viral
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Haematoma Infection
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Infection
|
|
subjects affected / exposed
|
4 / 2316 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
Infective Exacerbation of Chronic Obstructive Airways Disease
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Influenza
|
|
subjects affected / exposed
|
3 / 2316 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Laryngitis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lower Respiratory Tract Infection
|
|
subjects affected / exposed
|
6 / 2316 (0.26%) |
occurrences causally related to treatment / all
|
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
Lobar Pneumonia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Ludwig Angina
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Necrotising Fasciitis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Lung Infection
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Pneumonia
|
|
subjects affected / exposed
|
40 / 2316 (1.73%) |
occurrences causally related to treatment / all
|
0 / 44 |
deaths causally related to treatment / all
|
0 / 8 |
Osteomyelitis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Post Procedural Sepsis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Psoas Abscess
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Pulmonary Tuberculosis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Pyelonephritis
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Pyelonephritis Acute
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Respiratory Tract Infection
|
|
subjects affected / exposed
|
4 / 2316 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
Salmonella Bacteraemia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Salmonella Sepsis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Salmonellosis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Scrotal Abscess
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Sepsis
|
|
subjects affected / exposed
|
18 / 2316 (0.78%) |
occurrences causally related to treatment / all
|
0 / 18 |
deaths causally related to treatment / all
|
0 / 9 |
Septic Shock
|
|
subjects affected / exposed
|
3 / 2316 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
Staphylococcal Sepsis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
Upper Respiratory Tract Infection
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Urinary Tract Infection
|
|
subjects affected / exposed
|
34 / 2316 (1.47%) |
occurrences causally related to treatment / all
|
0 / 38 |
deaths causally related to treatment / all
|
0 / 2 |
Urinary Tract Infection Bacterial
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Urosepsis
|
|
subjects affected / exposed
|
25 / 2316 (1.08%) |
occurrences causally related to treatment / all
|
0 / 31 |
deaths causally related to treatment / all
|
0 / 3 |
Viral Upper Respiratory Tract Infection
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Wound Sepsis
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Metabolism and nutrition disorders
|
|
Cachexia
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
Decreased Appetite
|
|
subjects affected / exposed
|
5 / 2316 (0.22%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Dehydration
|
|
subjects affected / exposed
|
18 / 2316 (0.78%) |
occurrences causally related to treatment / all
|
0 / 19 |
deaths causally related to treatment / all
|
0 / 2 |
Diabetes Mellitus
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Diabetes Mellitus Inadequate Control
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Failure to Thrive
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
Fluid Retention
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hypercalcaemia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Hyperglycaemia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
Hyperkalaemia
|
|
subjects affected / exposed
|
4 / 2316 (0.17%) |
occurrences causally related to treatment / all
|
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
Hypoglycaemia
|
|
subjects affected / exposed
|
3 / 2316 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
Hypokalaemia
|
|
subjects affected / exposed
|
7 / 2316 (0.30%) |
occurrences causally related to treatment / all
|
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
Hyponatraemia
|
|
subjects affected / exposed
|
2 / 2316 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
Hypophosphataemia
|
|
subjects affected / exposed
|
1 / 2316 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |