Serious adverse events | Vandetanib | Placebo |
Total subjects affected by serious adverse events | | |
subjects affected / exposed | 160 / 619 (25.85%) | 63 / 303 (20.79%) |
number of deaths (all causes) | 474 | 230 |
number of deaths resulting from adverse events | | |
Vascular disorders | | |
Hypertension | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 7 / 619 (1.13%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 5 / 7 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Deep Vein Thrombosis | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 2 / 619 (0.32%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 3 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Arterial Thrombosis Limb | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Hypotension | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 0 | 1 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Jugular Vein Thrombosis | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 0 | 1 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Thrombophlebitis Superficial | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Visceral Arterial Ischaemia | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 0 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | | |
Cancer Pain | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Immune system disorders | | |
Drug Hypersensitivity | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 2 / 619 (0.32%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 2 / 2 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Anaphylactic Reaction | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
General disorders and administration site conditions | | |
Asthenia | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 5 / 619 (0.81%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 1 / 5 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Death | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 3 / 619 (0.48%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 3 | 0 / 0 |
deaths causally related to treatment / all | 0 / 3 | 0 / 0 |
Fatigue | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 3 / 619 (0.48%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 2 / 3 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Pyrexia | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 3 / 619 (0.48%) | 3 / 303 (0.99%) |
occurrences causally related to treatment / all | 0 / 3 | 0 / 4 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Chest Pain | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
General Physical Health Deterioration | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Malaise | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 0 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Pain | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Psychiatric disorders | | |
Confusional State | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 2 / 303 (0.66%) |
occurrences causally related to treatment / all | 0 / 0 | 0 / 2 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Anxiety | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Depression | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Injury, poisoning and procedural complications | | |
Femur Fracture | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 2 / 619 (0.32%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 2 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Femoral Neck Fracture | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Joint Dislocation | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Multiple Injuries | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 1 | 0 / 0 |
Pneumothorax Traumatic | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Wound | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Wrist Fracture | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Investigations | | |
Electrocardiogram T Wave Inversion | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Lipase Increased | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Neutrophil Count Decreased | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Cardiac disorders | | |
Atrial Fibrillation | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 2 / 619 (0.32%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 2 / 2 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Cardiac Failure | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 2 / 619 (0.32%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 2 | 0 / 0 |
deaths causally related to treatment / all | 1 / 2 | 0 / 0 |
Myocardial Infarction | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 2 / 619 (0.32%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 2 | 2 / 2 |
deaths causally related to treatment / all | 0 / 1 | 1 / 1 |
Angina Pectoris | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 0 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Arrhythmia | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Cardiac Arrest | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 1 | 0 / 0 |
Cardiac Valve Disease | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Pericardial Effusion | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 0 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Respiratory, thoracic and mediastinal disorders | | |
Dyspnoea | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 12 / 619 (1.94%) | 5 / 303 (1.65%) |
occurrences causally related to treatment / all | 1 / 14 | 2 / 6 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Pleural Effusion | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 5 / 619 (0.81%) | 5 / 303 (1.65%) |
occurrences causally related to treatment / all | 0 / 6 | 0 / 7 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Pulmonary Embolism | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 3 / 619 (0.48%) | 5 / 303 (1.65%) |
occurrences causally related to treatment / all | 0 / 3 | 0 / 5 |
deaths causally related to treatment / all | 0 / 1 | 0 / 0 |
Haemoptysis | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 3 / 619 (0.48%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 2 / 3 | 0 / 0 |
deaths causally related to treatment / all | 2 / 2 | 0 / 0 |
Cough | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 2 / 619 (0.32%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 2 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Pneumonia Aspiration | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 2 / 619 (0.32%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 2 | 0 / 0 |
deaths causally related to treatment / all | 0 / 1 | 0 / 0 |
Pneumonitis | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 2 / 619 (0.32%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 3 | 0 / 0 |
deaths causally related to treatment / all | 0 / 1 | 0 / 0 |
Acute Respiratory Distress Syndrome | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 1 | 0 / 0 |
deaths causally related to treatment / all | 1 / 1 | 0 / 0 |
Bronchial Haemorrhage | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 1 | 0 / 0 |
deaths causally related to treatment / all | 1 / 1 | 0 / 0 |
Bronchospasm | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 1 | 0 / 0 |
Idiopathic Pulmonary Fibrosis | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Pneumothorax | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Pulmonary Artery Thrombosis | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Pulmonary Haemorrhage | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 1 / 1 | 1 / 1 |
deaths causally related to treatment / all | 0 / 0 | 1 / 1 |
Respiratory Failure | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 1 |
deaths causally related to treatment / all | 0 / 1 | 0 / 1 |
Respiratory Tract Haemorrhage | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Blood and lymphatic system disorders | | |
Febrile Neutropenia | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 3 / 619 (0.48%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 3 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Anaemia | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 2 / 303 (0.66%) |
occurrences causally related to treatment / all | 0 / 0 | 1 / 2 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Thrombocytopenia | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 2 / 619 (0.32%) | 2 / 303 (0.66%) |
occurrences causally related to treatment / all | 0 / 2 | 0 / 2 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Leukopenia | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 0 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Neutropenia | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Nervous system disorders | | |
Convulsion | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 5 / 619 (0.81%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 1 / 5 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Cerebral Infarction | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 3 / 303 (0.99%) |
occurrences causally related to treatment / all | 0 / 0 | 2 / 4 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Cerebral Ischaemia | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 3 / 619 (0.48%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 3 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Cerebrovascular Accident | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 3 / 619 (0.48%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 1 / 3 | 0 / 1 |
deaths causally related to treatment / all | 0 / 2 | 0 / 0 |
Cerebral Haemorrhage | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Cognitive Disorder | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Dizziness | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Encephalitis | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Loss Of Consciousness | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 0 | 2 / 2 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Paraesthesia | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Partial Seizures | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Somnolence | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Subarachnoid Haemorrhage | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Syncope | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 0 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Transient Ischaemic Attack | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Tremor | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Eye disorders | | |
Diplopia | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Vision Blurred | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Visual Acuity Reduced | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Ear and labyrinth disorders | | |
Deafness | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Vertigo | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 0 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Gastrointestinal disorders | | |
Diarrhoea | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 8 / 619 (1.29%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 5 / 8 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Vomiting | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 4 / 619 (0.65%) | 3 / 303 (0.99%) |
occurrences causally related to treatment / all | 2 / 5 | 1 / 3 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Nausea | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 2 / 619 (0.32%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 2 / 2 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Abdominal Distension | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Abdominal Pain | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Ascites | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 0 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Constipation | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Duodenal Ulcer | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Enteritis | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Gastrointestinal Perforation | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 0 | 1 / 1 |
deaths causally related to treatment / all | 0 / 0 | 1 / 1 |
Gastrooesophageal Reflux Disease | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Gingival Pain | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Ileus Paralytic | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Intestinal Haemorrhage | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 0 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 1 |
Intestinal Perforation | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 0 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 1 |
Neutropenic Colitis | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Pancreatitis | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Paraesthesia Oral | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 0 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Pneumatosis Intestinalis | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Proctalgia | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Subileus | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 0 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Renal and urinary disorders | | |
Urinary Retention | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 2 / 303 (0.66%) |
occurrences causally related to treatment / all | 0 / 0 | 0 / 2 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Calculus Urinary | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 0 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Renal Failure | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Renal Failure Acute | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Urinary Incontinence | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Hepatobiliary disorders | | |
Bile Duct Stenosis | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 0 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Cytolytic Hepatitis | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Skin and subcutaneous tissue disorders | | |
Rash | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 4 / 619 (0.65%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 4 / 4 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Stevens-Johnson Syndrome | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 3 / 619 (0.48%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 2 / 3 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Photosensitivity Reaction | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 2 / 619 (0.32%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 2 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Dermatitis Allergic | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Dry Skin | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Erythema | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Erythema Multiforme | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 2 / 2 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Rash Pruritic | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Musculoskeletal and connective tissue disorders | | |
Back Pain | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 2 / 619 (0.32%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 2 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Musculoskeletal Pain | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 2 / 619 (0.32%) | 2 / 303 (0.66%) |
occurrences causally related to treatment / all | 0 / 3 | 0 / 2 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Arthralgia | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Bone Pain | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Muscle Twitching | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Musculoskeletal Chest Pain | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Myalgia | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Neck Pain | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Osteoarthritis | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 0 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Pain In Extremity | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Endocrine disorders | | |
Hyperthyroidism | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Metabolism and nutrition disorders | | |
Dehydration | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 4 / 619 (0.65%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 1 / 4 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Decreased Appetite | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 2 / 619 (0.32%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 2 / 2 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Hyperglycaemia | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 2 / 619 (0.32%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 2 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Hyponatraemia | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 2 / 619 (0.32%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 1 / 2 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Hypercalcaemia | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 0 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Hypoglycaemia | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Infections and infestations | | |
Pneumonia | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 21 / 619 (3.39%) | 6 / 303 (1.98%) |
occurrences causally related to treatment / all | 0 / 26 | 0 / 7 |
deaths causally related to treatment / all | 0 / 3 | 0 / 3 |
Sepsis | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 3 / 619 (0.48%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 1 / 3 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 1 |
Lung Infection | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 2 / 619 (0.32%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 2 | 0 / 1 |
deaths causally related to treatment / all | 0 / 1 | 0 / 0 |
Urinary Tract Infection | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 2 / 619 (0.32%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 2 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Arthritis Bacterial | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 0 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Bacterial Sepsis | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 0 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 1 |
Bronchitis | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 0 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Catheter Site Infection | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Cellulitis | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Clostridial Infection | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Empyema | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 0 / 619 (0.00%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 0 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Gastroenteritis | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Injection Site Abscess | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Lobar Pneumonia | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 1 | 0 / 0 |
Lower Respiratory Tract Infection | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 1 |
Pharyngitis | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Staphylococcal Sepsis | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Subcutaneous Abscess | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Tracheitis | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Upper Respiratory Tract Infection | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 1 / 303 (0.33%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 1 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |
Urosepsis | | |
alternative dictionary used: MedDRA 12.1 | | |
alternative assessment type: Systematic | | |
subjects affected / exposed | 1 / 619 (0.16%) | 0 / 303 (0.00%) |
occurrences causally related to treatment / all | 0 / 1 | 0 / 0 |
deaths causally related to treatment / all | 0 / 0 | 0 / 0 |