Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 7:04 PM
Ignite Modification Date: 2025-12-25 @ 4:38 PM
NCT ID: NCT00444457
Description: Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Frequency Threshold: 0
Time Frame: Baseline through 6 Month Follow-up after last study vaccination (18 Months). Local reactions and systemic events assessed within 7 days of dose: Infant Series Dose 1, 2, and 3 at 2, 4, and 6 months of age, respectively; Toddler Dose at 12 months of age.
Study: NCT00444457
Study Brief: Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Infant Series 13vPnC (Pilot Lot 1) Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series). Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=407; systematic (solicited) Local Reactions N=262; systematic (solicited) Systemic Events N=373. None None 13 486 407 486 View
Infant Series 13vPnC (Pilot Lot 2) Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series). Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=394; systematic (solicited) Local Reactions N=262; systematic (solicited) Systemic Events N=364. None None 23 483 394 483 View
Infant Series 13vPnC (Manufacturing Lot) Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series). Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=402; systematic (solicited) Local Reactions N=250; systematic (solicited) Systemic Events N=386. None None 17 483 402 483 View
Infant Series 7vPnC Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series). Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=207; systematic (solicited) Local Reactions N=142; systematic (solicited) Systemic Events N=198. None None 15 244 207 244 View
After the Infant Series Combined 13vPnC Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1, 2, or manufacturing lot at 2, 4, and 6 months of age (assessment at 7 months of age; 1 month after the infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age(assessment at 7 months of age; 1 month after the infant series). None None 25 1445 88 1445 View
After the Infant Series 7vPnC Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (assessment at 7 months of age; 1 month after the infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age(assessment at 7 months of age; 1 month after the infant series). None None 3 244 11 244 View
Toddler Dose Combined 13vPnC Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1, 2, or manufacturing lot at 12 months of age; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age. Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=434; systematic (solicited) Local Reactions N=473; systematic (solicited) Systemic Events N=771. None None 9 1210 771 1210 View
Toddler Dose 7vPnC Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age. Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=75; systematic (solicited) Local Reactions N=83; systematic (solicited) Systemic Events N=128. None None 1 208 128 208 View
Post Toddler Dose 6-Month Follow-up Combined 13vPnC Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1, 2, or manufacturing lot at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose) ; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose). None None 21 1443 37 1443 View
Post Toddler Dose 6-Month Follow-up 7vPnC Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose) ; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose). None None 7 244 9 244 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Haematochezia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intussusception NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Sudden infant death syndrome NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Irritability NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site rash NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Allergy to vaccine NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Food allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory syncytial virus bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory syncytial virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Croup infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Meningitis aseptic NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Meningitis enteroviral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urosepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Eczema herpeticum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Periorbital cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Perirectal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Staphylococcal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Streptococcal bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Subcutaneous abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Endocarditis bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis media acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Joint injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Thermal burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Near drowning NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Skull fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Accidental overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Foreign body trauma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Abnormal loss of weight NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Failure to thrive NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Febrile convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Respiratory distress NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Apparent life threatening event NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Bronchial hyperreactivity NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Productive cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Stridor NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumonia aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary oedema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory arrest NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Petechiae NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Lymphadenitis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Cyanosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Pulmonary valve stenosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Dacryostenosis acquired NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Abscess oral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpangina NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Impetigo NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Osteomyelitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis pharyngeal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rectal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral rash NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Lymphadenopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Lymphadenitis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocythaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Iron deficiency anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Cyanosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Plagiocephaly NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Dacryostenosis congenital NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Hydrocele NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Macrocephaly NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Pectus excavatum NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Ankyloglossia congenital NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Atrial septal defect NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Brachycephaly NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Hemihypertrophy NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Hip dysplasia NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Hypospadias NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Laryngomalacia NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Naevus flammeus NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Phimosis NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Pulmonary valve stenosis congenital NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Skull malformation NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Ventricular septal defect NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Von Willebrand's disease NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Congenital neavus NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Tibial torsion NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Ear pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Middle ear effusion NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Cerumen impaction NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Otorrhoea NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Deafness neurosensory NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
External ear inflammation NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Tympanic membrane disorder NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Tympanic membrane perforation NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Deafness NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Precocious puberty NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Dacryostenosis acquired NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye discharge NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Strabismus NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Lacrimation increased NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Blepharitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye swelling NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eyelid oedema NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eyelid ptosis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Dark circles under eyes NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye irritation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Heterophoria NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Hypermetropia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Ocular hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Pupillary reflex impaired NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Pupils unequal NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Scleral disorder NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Teething NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Infantile spitting up NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Haematochezia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Stomach discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Umbilical hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abnormal faeces NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anal fissure NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Frequent bowel movements NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Infantile colic NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Mouth ulceration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Allergic colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyschezia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Enteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gingval cyst NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gingval ulceration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Melaena NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Mouth cyst NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Oral disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Rectal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Regurgitation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Retching NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Tongue discolouration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Tongue geographic NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting projectile NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Inguinal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Aphthous stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anal skin tags NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Irritability NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site induration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Xerosis NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cyst NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site bruising NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site dryness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site haemorrhage NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site rash NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site haematoma NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site urticaria NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Developmental delay NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Localised oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hyperbilirubinaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Milk allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Drug hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Food allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Allergy to vaccine NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Seasonal allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Anaphylactic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Croup infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis media acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory syncytial virus bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory syncytial virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Candida nappy rash NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Fungal skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Impetigo NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Skin candida NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Conjunctivitis bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpangina NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Roseola NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Acute sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis externa NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Dacryocystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Conjunctivitis infective NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Eye infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis rotavirus NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Intertrigo candida NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Paronychia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Varicella NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Acarodermatitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Beta haemolytic streptococcal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Body tinea NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Dermatophytosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Enteritis infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Fungal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Hordeolum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Periorbital cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis streptococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rash pustular NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Staphylococcal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tinea capitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tinea infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Abscess oral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Breast cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis of male external genital organ NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis staphylococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Diarrhoea infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Eczema herpeticum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Eczema infected NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Erysipelas NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Erythema infectiosum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Folliculitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Furuncle NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis salmonella NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Genital candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Labyrinthitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Parotitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Perirectal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pyelonephritis acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rotavirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Scarlet fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Staphylococcal skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral diarrhoea NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Vulvovaginal mycotic infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis media chronic NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Coxsackie viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral rash NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Dermatitis infected NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Hand-foot-and-mouth disease NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Acute tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Adenovirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Exanthema subitum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lyme disease NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Chronic sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Traumatic brain injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Arthropod bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Excoriation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Head injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Chemical burns of eye NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Concussion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Corneal abrasion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Lower limb fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Skin laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Thermal burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Animal bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Arthropod sting NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Burns second degree NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Joint sprain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Mouth injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Torus fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Vaccination complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Cardiac murmur NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Cardiac murmur functional NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Head circumference abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
White blood cell count increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood lead increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Body height below normal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Liver function test abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Weight gain poor NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Food intolerance NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Feeding disorder neonatal NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Cow's milk intolerance NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Increased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Lactose intolerance NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Metabolic acidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Oral intake reduced NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Overweight NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Failure to thrive NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Underweight NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Torticollis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Head deformity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Foot deformity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle twiching NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Knee deformity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Haemangioma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Haemangioma of skin NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Melanocytic naevus NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Benign neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Benign penile neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Lipoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Fibrous histiocytoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Hypersomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypertonia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Febrile convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Head titubation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hyporeflexia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypotonia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Lethargy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Poor quality sleep NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Psychomotor hyperactivity NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Subdural effusion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebral cyst NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Speech disorder developmental NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Gross motor delay NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cephalhaematoma NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Neonatal disorder NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Umbilical granuloma NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Sleep disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Crying NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Breath holding NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Initial insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Restlessness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Screaming NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Tic NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Urine odour abnormal NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Hydronephrosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Vesicoureteric reflux NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal tubular acidosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Vulval disorder NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Penile adhesion NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Balanitis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Breast cyst NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Genital discomfort NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Gynaecomastia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Genital labial adhesions NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Genital rash NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Penile oedema NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Bronchial hyperreactivity NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sneezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinitis allergic NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sinus congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Bronchospasm NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dysphonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Stridor NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Upper respiratory tract congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pharyngolaryngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Tracheomalacia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Upper respiratory tract inflammation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Choking NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Lower respiratory tract inflammation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Postnasal drip NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinitis seasonal NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhonchi NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Throat irritation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis diaper NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Seborrhoeic dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis atopic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Seborrhoea NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Heat rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dandruff NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash erythematous NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash macular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Acne infantile NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Drug eruption NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Intertrigo NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Petechiae NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin lesion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Acanthosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Ingrowing nail NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Post inflammatory pigmentation change NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin irritation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Cafe au lait spots NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis allergic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermographism NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Eczema infantile NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Livedo reticularis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Nail discolouration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pityriasis alba NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Psoriasis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Purpura NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash neonatal NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash pruritic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash vesicular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin fissures NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin nodule NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Subcutaneous nodule NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Urticaria papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Keratosis pilaris NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Vitiligo NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Acrodermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Blister NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermal cyst NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis acneiform NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pityriasis rosea NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Overfeeding of infant NON_SYSTEMATIC_ASSESSMENT Social circumstances MedDRA View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Tenderness (any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Tenderness (any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Tenderness (any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Tenderness (significant) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Tenderness (significant) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Tenderness (significant) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Induration (any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Induration (any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Induration (any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Induration (mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Induration (mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Induration (mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Induration (moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Induration (moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Induration (moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Induration (severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Induration (severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Induration (severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Erythema (any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Erythema (any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Erythema (any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Erythema (mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Erythema (mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Erythema (mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Erythema (moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Erythema (moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Erythema (moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Erythema (severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Erythema (severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Erythema (severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local reactions View
Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever > 39 degrees C but ≤ 40 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever > 39 degrees C but ≤ 40 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever > 39 degrees C but ≤ 40 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever > 40 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever > 40 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever > 40 degrees C SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased appetite SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased appetite SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased appetite SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Increased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Increased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Increased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Hives (Urticaria) SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Hives (Urticaria) SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Hives (Urticaria) SYSTEMATIC_ASSESSMENT General disorders Systemic Events View