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:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-26 @ 1:20 AM
NCT ID:
NCT00090233
Description:
Participants listed in SAE tables (34904-RotaTeq; 34862-Placebo) are those who received study treatment. Other AEs were reported for a pre-defined subset who received ≥1 dose (4808-RotaTeq; 4796-Placebo). Although a participant may have had ≥ 2 AEs they are counted only once in a category. The same participant may appear in different categories.
Frequency Threshold:
1
Time Frame:
Participants in this study were followed for all serious adverse events (SAEs) and other adverse events (AEs), for up to 42 days following each study vaccination
Study:
NCT00090233
Study Brief:
Rotavirus Efficacy and Safety Trial (REST)(V260-006)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| RotaTeq™ | Three oral doses (\~6.5x10\^7 to \~1.2x10\^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart. The Not Completed total includes participants discontinued at any time before the completion of the third study vaccination and/or the 42-day safety follow-up period post vaccination 3. | None | None | 863 | 34904 | 4000 | 4800 | View |
| Placebo | Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart. The Not Completed total includes participants discontinued at any time before the completion of the third study vaccination and/or the 42-day safety follow-up period post vaccination 3. | None | None | 955 | 34862 | 4047 | 4787 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Brain death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.1) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.1) | View |
| Cyst | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.1) | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.1) | View |
| Drowning | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.1) | View |
| Fever neonatal | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.1) | View |
| Hernia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.1) | View |
| Impetigo | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Staring | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.1) | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.1) | View |
| Idiopathic thrombocytopenic purpura | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (8.1) | View |
| Coarctation of the aorta | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (8.1) | View |
| Gastrointestinal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Arthritis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Dysentery | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Pyelonephritis acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.1) | View |
| Loss of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (8.1) | View |
| Lymphadenitis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (8.1) | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (8.1) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (8.1) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (8.1) | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.1) | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.1) | View |
| Cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.1) | View |
| Cardiopulmonary failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.1) | View |
| Cyanosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.1) | View |
| Atrial septal defect | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (8.1) | View |
| Cerebral palsy | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (8.1) | View |
| Congenital cystic kidney disease | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (8.1) | View |
| Congenital intestinal malformation | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (8.1) | View |
| Cryptorchism | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (8.1) | View |
| Cystic fibrosis | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (8.1) | View |
| Developmental glaucoma | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (8.1) | View |
| Glycogen storage disease type ib | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (8.1) | View |
| Hip dysplasia | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (8.1) | View |
| Hydrocele | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (8.1) | View |
| Kidney malformation | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (8.1) | View |
| Polycystic liver disease | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (8.1) | View |
| Pulmonary artery stenosis congenital | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (8.1) | View |
| Pyloric stenosis | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (8.1) | View |
| Retinoblastoma | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (8.1) | View |
| Ventricular septal defect | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (8.1) | View |
| Chalazion | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (8.1) | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (8.1) | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Anal fissure | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Anal fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Anal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Anal skin tags | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Aphthous stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Cheilitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Diarrhoea haemorrhagic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Duodenitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Enteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Faecaloma | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Gastrointestinal inflammation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Haematemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Infantile colic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Inguinal hernia, obstructive | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Intussusception | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Oesophageal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Rectal prolapse | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Reflux oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Regurgitation of food | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Retching | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Umbilical hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Varices oesophageal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Volvulus of bowel | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Injection site inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.1) | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.1) | View |
| Near sudden infant death syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.1) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.1) | View |
| Sudden death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.1) | View |
| Sudden infant death syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.1) | View |
| Hepatic steatosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (8.1) | View |
| Hepatomegaly | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (8.1) | View |
| Anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (8.1) | View |
| Food allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (8.1) | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (8.1) | View |
| Milk allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (8.1) | View |
| Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Abscess neck | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Acute tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Adenovirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Amoebic dysentery | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Anal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Botulism | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Bronchitis acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Bronchitis acute viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Bronchitis chronic | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Bronchitis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Bronchopneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Campylobacter intestinal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Catheter site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Cellulitis staphylococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Chest wall abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Clostridium colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Coxsackie viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Croup infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Eczema infected | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Enterocolitis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Enterovirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Escherichia sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Escherichia urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Exanthema subitum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Febrile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Gastroenteritis adenovirus | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Gastroenteritis rotavirus | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Gastroenteritis salmonella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Gastrointestinal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Groin abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Haemophilus sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Kawasaki's disease | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Laryngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Laryngotracheitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Laryngotracheo bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Lobar pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Meningitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Meningitis aseptic | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Meningitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Meningitis enteroviral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Meningitis haemophilus | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Meningitis streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Meningitis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Otitis externa | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Otitis media acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Parainfluenzae virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Parotitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Perianal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Perineal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Periorbital cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Pertussis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Pneumococcal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Pneumococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Pneumococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Pneumocystis jiroveci pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Pneumonia bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Pneumonia primary atypical | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Pneumonia respiratory syncytial viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Pneumonia viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Pseudocroup | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Pyelocystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Respiratory syncytial virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Respiratory tract infection viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Roseola | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Salmonellosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Scrotal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Staphylococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Subcutaneous abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Tonsillitis streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Tuberculosis of peripheral lymph nodes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Varicella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Viral pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Viral rash | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Accidental overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Burns second degree | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Extradural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Fractured skull depressed | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Heat exhaustion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Injury asphyxiation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Limb injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Multiple fractures | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Post procedural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Skull fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Subdural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Subdural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Tibia fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Upper limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.1) | View |
| Body temperature increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1) | View |
| Occult blood positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1) | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.1) | View |
| Acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.1) | View |
| Cow's milk intolerance | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.1) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.1) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.1) | View |
| Diet refusal | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.1) | View |
| Failure to thrive | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.1) | View |
| Feeding disorder | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.1) | View |
| Feeding disorder neonatal | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.1) | View |
| Food intolerance | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.1) | View |
| Hyperinsulinaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.1) | View |
| Hypernatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.1) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.1) | View |
| Lactose intolerance | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.1) | View |
| Metabolic acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.1) | View |
| Weight gain poor | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.1) | View |
| Chondromalacia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | View |
| Growth retardation | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | View |
| Brain neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) | View |
| Haemangioma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) | View |
| Neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) | View |
| Neuroblastoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) | View |
| Pineal parenchymal neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) | View |
| Anoxic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Brain oedema | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Epilepsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Febrile convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Hemiplegia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Hydrocephalus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Hypotonia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Hypoxic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Infantile spasms | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Intraneural cyst | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Myoclonus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Nystagmus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Spinal cord haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Status epilepticus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Subarachnoid haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Syncope vasovagal | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Thalamus haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Vocal cord paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.1) | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.1) | View |
| Apathy | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.1) | View |
| Breath holding | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.1) | View |
| Crying | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.1) | View |
| Eating disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.1) | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.1) | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.1) | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (8.1) | View |
| Vesicoureteric reflux | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (8.1) | View |
| Balanitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (8.1) | View |
| Epididymitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (8.1) | View |
| Phimosis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (8.1) | View |
| Testicular torsion | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (8.1) | View |
| Acute respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Apnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Apnoeic attack | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Bronchial hyperactivity | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Bronchospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Choking | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Chronic respiratory disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Interstitial lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Laryngospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Neonatal apnoeic attack | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Neonatal respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Obstructive airways disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Pulmonary congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Pulmonary haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Respiratory acidosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Respiratory disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Sleep apnoea syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Status asthmaticus | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Tachypnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Tracheomalacia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Dermatitis allergic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.1) | View |
| Dermatitis atopic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.1) | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.1) | View |
| Eczema infantile | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.1) | View |
| Lichen sclerosus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.1) | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.1) | View |
| Purpura | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.1) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.1) | View |
| Seborrhoea | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.1) | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.1) | View |
| Urticaria pigmentosa | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.1) | View |
| Child abuse | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA (8.1) | View |
| Child neglect | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA (8.1) | View |
| Overfeeding of infant | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA (8.1) | View |
| Circulatory collapse | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.1) | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.1) | View |
| Haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.1) | View |
| Pallor | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.1) | View |
| Vasculitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (8.1) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Infantile colic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Regurgitation of food | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Teething | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.1) | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.1) | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.1) | View |
| Bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Candida nappy rash | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.1) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.1) | View |
| Crying | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.1) | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.1) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.1) | View |
| Dermatitis diaper | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.1) | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.1) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.1) | View |