| Acute prerenal failure | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Apparent life-threatening event | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Acute Respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0002 affected458 at risk
|
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0002 affected458 at risk
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0006 affected458 at risk
|
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0002 affected458 at risk
|
| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0002 affected458 at risk
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0003 affected458 at risk
|
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG00017 affected458 at risk
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0004 affected458 at risk
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0003 affected458 at risk
|
| Increased bronchial secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Infantile apneic attack | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0002 affected458 at risk
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Mediastinal mass | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0004 affected458 at risk
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0002 affected458 at risk
|
| Pneumopathy | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0004 affected458 at risk
|
| Prolonged expiration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0002 affected458 at risk
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0002 affected458 at risk
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0003 affected458 at risk
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG00016 affected458 at risk
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0002 affected458 at risk
|
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0002 affected458 at risk
|
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Use of accessory respiratory muscles | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0005 affected458 at risk
|
| Bacterial infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0002 affected458 at risk
|
| Bronchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0003 affected458 at risk
|
| Bronchiolitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG00028 affected458 at risk
|
| Escherichia urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Gastroenterocolitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Gastroenteritis | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0006 affected458 at risk
|
| Haemophilus infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0002 affected458 at risk
|
| Influenza | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Laryngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0002 affected458 at risk
|
| Lung infection pseudomonal | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Meningitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0002 affected458 at risk
|
| Obstructive bronchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Otitis media recurrent | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Parainfluenzae viral laryngotracheobronchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Parainfluenzae virus infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Pertussis | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Pharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0004 affected458 at risk
|
| Pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0008 affected458 at risk
|
| Pneumonia bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0003 affected458 at risk
|
| Pneumonia chlamydial | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Pneumonia streptococcal | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Pneumonia viral | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0007 affected458 at risk
|
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0002 affected458 at risk
|
| Sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Sepsis neonatal | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Viral infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0005 affected458 at risk
|
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0003 affected458 at risk
|
| Convulsion | Nervous system disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Hydrocephalus | Nervous system disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Infantile spasms | Nervous system disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Loss of consciousness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Somnolence | Nervous system disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Milk allergy | Immune system disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Gastrointestinal atoma complication | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Retinopathy of prematurity | Eye disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Bradycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Cyanosis | Cardiac disorders | MedDRA 16.0 | Systematic Assessment | | - EG00011 affected458 at risk
|
| Jugular vein thrombosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Haemodynamic instability | Vascular disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Heart failure | Cardiac disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Pallor | Vascular disorders | MedDRA 16.0 | Systematic Assessment | | - EG0002 affected458 at risk
|
| Subvalvular aortic stenosis | Cardiac disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0002 affected458 at risk
|
| Abdominal mass | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0009 affected458 at risk
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG00011 affected458 at risk
|
| Haematochezia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0005 affected458 at risk
|
| Meconium ileus | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Megacolon | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Reflux gastritis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Stools watery | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Volvulus of small bowel | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment | | - EG00011 affected458 at risk
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment | | - EG0004 affected458 at risk
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment | | - EG0004 affected458 at risk
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Feeding disorder | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Food intolerance | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Hypophagia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment | | - EG0003 affected458 at risk
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Metabolic alkalosis | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Underweight | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Weight gain poor | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Death | General disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Fever | General disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Hyperthermia | General disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment | | - EG00018 affected458 at risk
|
| Malaise | General disorders | MedDRA 16.0 | Systematic Assessment | | - EG0003 affected458 at risk
|
| Mucosal Inflammation | General disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Irritability | General disorders | MedDRA 16.0 | Systematic Assessment | | - EG0003 affected458 at risk
|
| General physical health deterioration | General disorders | MedDRA 16.0 | Systematic Assessment | | - EG0002 affected458 at risk
|
| Arterial septal defect | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Atrioventricular septal defect | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Intestinal malrotation | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Cryptorchism | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Heart disease congenital | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Hypospadias | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment | | - EG0002 affected458 at risk
|
| Laryngomalacia | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Pilonidal cyst congenital | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Pyloric stenosis | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Ventricular septal defect | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment | | - EG0002 affected458 at risk
|
| Anaemia neonatal | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Hepatoblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Haemangioma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Skin neoplasm bleeding | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| CSF test abnormal | Investigations | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Oxygen saturation decreased | Investigations | MedDRA 16.0 | Systematic Assessment | | - EG0005 affected458 at risk
|
| Oxygen consumption increased | Investigations | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Respiratory syncytial virus test positive | Investigations | MedDRA 16.0 | Systematic Assessment | | - EG0003 affected458 at risk
|
| Urine analysis abnormal | Investigations | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Urine output decreased | Investigations | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Weight decreased | Investigations | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Agitation | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Tracheostomy | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Inguinal hernia repair | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Oral surgery | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Ophthalmic fluid drainage | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Vascular operation | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Hypotonia neonatal | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment | | - EG0001 affected458 at risk
|
| Feeding disorder of infancy or early childhood | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment | | - EG0002 affected458 at risk
|
| Feeding disorder neonatal | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment | | - EG0003 affected458 at risk
|