| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0022 affected30 at risk
|
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment | | - EG0002 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment | | - EG0002 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Congenital naevus | Congenital, familial and genetic disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0012 affected31 at risk
- EG0022 affected30 at risk
|
| Conjucunctival Hemorrhage | Eye disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment | | - EG0004 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Fat Tissue Increased | General disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment | | - EG0002 affected30 at risk
- EG0011 affected31 at risk
- EG0023 affected30 at risk
|
| Bacterial Sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Scratch | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0010 affected31 at risk
- EG0022 affected30 at risk
|
| Cardiac murmur | Investigations | MedDRA (19.0) | Systematic Assessment | | - EG0005 affected30 at risk
- EG0014 affected31 at risk
- EG0024 affected30 at risk
|
| Gamma-glutamyl transferase increased | Investigations | MedDRA (19.0) | Systematic Assessment | | - EG0002 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Haematocrit decreased | Investigations | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0012 affected31 at risk
- EG0021 affected30 at risk
|
| Haemoglobin decreased | Investigations | MedDRA (19.0) | Systematic Assessment | | - EG0002 affected30 at risk
- EG0011 affected31 at risk
- EG0021 affected30 at risk
|
| Medical observation | Investigations | MedDRA (19.0) | Systematic Assessment | | - EG0002 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Reticulocyte count increased | Investigations | MedDRA (19.0) | Systematic Assessment | | - EG0002 affected30 at risk
- EG0013 affected31 at risk
- EG0021 affected30 at risk
|
| Abnormal Loss Of Weight | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Acne infantile | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0011 affected31 at risk
- EG0022 affected30 at risk
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | | - EG0002 affected30 at risk
- EG0010 affected31 at risk
- EG0021 affected30 at risk
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | | - EG0002 affected30 at risk
- EG0013 affected31 at risk
- EG0023 affected30 at risk
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | | - EG0005 affected30 at risk
- EG0015 affected31 at risk
- EG0020 affected30 at risk
|
| Erythema toxicum neonatorum | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0012 affected31 at risk
- EG0023 affected30 at risk
|
| Milia | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0011 affected31 at risk
- EG0022 affected30 at risk
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | | - EG0003 affected30 at risk
- EG0011 affected31 at risk
- EG0023 affected30 at risk
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | | - EG0002 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Seborrhoea | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | | - EG0002 affected30 at risk
- EG0011 affected31 at risk
- EG0022 affected30 at risk
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | | - EG0003 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Platelet Toxicity | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0010 affected31 at risk
- EG0021 affected30 at risk
|
| Supraventricular Tachycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Ventricular Hypertrophy | Cardiac disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Ankyloglossia Congenital | Congenital, familial and genetic disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Atrial Septal Defect | Congenital, familial and genetic disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Dacryostenosis Congenital | Congenital, familial and genetic disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0010 affected31 at risk
- EG0021 affected30 at risk
|
| Hydrocele | Congenital, familial and genetic disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Patent Ductus Arteriosus | Congenital, familial and genetic disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Middle Ear Effusion | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Eye Discharge | Eye disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Ocular Icterus | Eye disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0010 affected31 at risk
- EG0021 affected30 at risk
|
| Retinal Haemorrhage | Eye disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Strabismus | Eye disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Infantile Colic | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Infantile Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0021 affected30 at risk
|
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Injection Site Erythema | General disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Abo Incompatibility | Immune system disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0010 affected31 at risk
- EG0021 affected30 at risk
|
| Candida Nappy Rash | Infections and infestations | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Fungal Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Meningitis Viral | Infections and infestations | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Oral Candidiasis | Infections and infestations | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0010 affected31 at risk
- EG0021 affected30 at risk
|
| Otitis Media | Infections and infestations | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Skin Candida | Infections and infestations | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Viral Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0010 affected31 at risk
- EG0021 affected30 at risk
|
| Skin Abrasion | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Aspartate Aminotransferase Increased | Investigations | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Bilirubin Conjugated Increased | Investigations | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Blood Bicarbonate Decreased | Investigations | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Blood Bilirubin Increased | Investigations | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Carbon Dioxide Decreased | Investigations | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0010 affected31 at risk
- EG0021 affected30 at risk
|
| Haematocrit Abnormal | Investigations | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Neutrophil Count Decreased | Investigations | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Platelet Count Decreased | Investigations | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Red Blood Cell Count Decreased | Investigations | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Respiratory Syncytial Virus Test Positive | Investigations | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| White Blood Cell Count Increased | Investigations | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Feeding Intolerance | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Foot Deformity | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0010 affected31 at risk
- EG0021 affected30 at risk
|
| Hypotonia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Lethargy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Tremor | Nervous system disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Umbilical Granuloma | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Jaundice Neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Penile Haemorrhage | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Neonatal Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0010 affected31 at risk
- EG0021 affected30 at risk
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Cafe Au Lait Spots | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0010 affected31 at risk
- EG0021 affected30 at risk
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Exfoliative Rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Generalised Erythema | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Melanosis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0011 affected31 at risk
- EG0020 affected30 at risk
|
| Rash Erythematous | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0011 affected31 at risk
- EG0021 affected30 at risk
|
| Rash Neonatal | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0010 affected31 at risk
- EG0021 affected30 at risk
|
| Rash Papular | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0010 affected31 at risk
- EG0021 affected30 at risk
|
| Skin Disorder | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0010 affected31 at risk
- EG0021 affected30 at risk
|
| Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Skin Sensitisation | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | | - EG0001 affected30 at risk
- EG0010 affected31 at risk
- EG0020 affected30 at risk
|
| Transient Neonatal Pustular Melanosis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | | - EG0000 affected30 at risk
- EG0010 affected31 at risk
- EG0021 affected30 at risk
|