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 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
NCT ID:
NCT01155193
Description:
Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
Frequency Threshold:
0
Time Frame:
During RSV season (June to September) from 2002 to 2016
Study:
NCT01155193
Study Brief:
Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Palivizumab | Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season (September to June) from 2002 to 2016. | None | None | 701 | 29468 | 34 | 29468 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| IRON DEFICIENCY ANAEMIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.1) | View |
| LEUKOCYTOSIS | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.1) | View |
| LEUKOPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.1) | View |
| THROMBOCYTOPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.1) | View |
| AORTIC VALVE STENOSIS | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| BRADYCARDIA | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| CARDIAC ARREST | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| CARDIAC DISORDER | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| CARDIAC FAILURE | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| CARDIOPULMONARY FAILURE | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| CARDIOVASCULAR INSUFFICIENCY | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| CYANOSIS | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| MYOCARDITIS | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| RESTRICTIVE CARDIOMYOPATHY | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| RIGHT VENTRICULAR DYSFUNCTION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| ATRIAL SEPTAL DEFECT | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (19.1) | View |
| CONGENITAL CENTRAL HYPOVENTILATION SYNDROME | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (19.1) | View |
| FALLOT'S TETRALOGY | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (19.1) | View |
| HEART DISEASE CONGENITAL | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (19.1) | View |
| HYPOPLASTIC LEFT HEART SYNDROME | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (19.1) | View |
| LISSENCEPHALY | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (19.1) | View |
| WOLF-HIRSCHHORN SYNDROME | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (19.1) | View |
| ABDOMINAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| DIAPHRAGMATIC HERNIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| DIARRHOEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| FLATULENCE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| HAEMATOCHEZIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| INGUINAL HERNIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| INTESTINAL OBSTRUCTION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| NECROTISING COLITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| UMBILICAL HERNIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| VOMITING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| ADVERSE DRUG REACTION | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| ADVERSE EVENT | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| CARDIAC DEATH | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| DEATH | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| GENERAL PHYSICAL HEALTH DETERIORATION | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| HYPOTHERMIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| MALAISE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| OEDEMA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| PYREXIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| ANAPHYLACTIC REACTION | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (19.1) | View |
| ADENOVIRAL UPPER RESPIRATORY INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| BRONCHIOLITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| BRONCHITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| BRONCHITIS VIRAL | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| CELLULITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| CONJUNCTIVITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| DEVICE RELATED SEPSIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| EXANTHEMA SUBITUM | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| GASTROENTERITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| GASTROENTERITIS NOROVIRUS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| GASTROENTERITIS ROTAVIRUS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| INFECTIVE PERICARDIAL EFFUSION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| INFLUENZA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| LARYNGOTRACHEITIS OBSTRUCTIVE | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| MYELITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| NASOPHARYNGITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| OSTEOMYELITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| OTITIS MEDIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| PERTUSSIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| PNEUMONIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| PNEUMONIA BACTERIAL | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| PNEUMONIA ESCHERICHIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| PNEUMONIA INFLUENZAL | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| PNEUMONIA VIRAL | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| PSEUDOCROUP | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| RESPIRATORY SYNCYTIAL VIRUS BRONCHITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| RESPIRATORY SYNCYTIAL VIRUS INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| RESPIRATORY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| RESPIRATORY TRACT INFECTION VIRAL | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| SEPSIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| STAPHYLOCOCCAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| SUPERINFECTION BACTERIAL | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| UPPER RESPIRATORY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| VIRAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| INJECTION RELATED REACTION | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| LOWER LIMB FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| ANTIMICROBIAL SUSCEPTIBILITY TEST RESISTANT | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BODY TEMPERATURE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BREATH SOUNDS ABNORMAL | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| CATHETERISATION CARDIAC | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| INFLUENZA VIRUS TEST POSITIVE | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| OXYGEN SATURATION DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| RESPIRATORY SYNCYTIAL VIRUS TEST POSITIVE | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| STAPHYLOCOCCUS TEST POSITIVE | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| WEIGHT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| DECREASED APPETITE | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| DEHYDRATION | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| DIET REFUSAL | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| FAILURE TO THRIVE | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| FLUID INTAKE REDUCED | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| LACTOSE INTOLERANCE | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| MALNUTRITION | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| METABOLIC ACIDOSIS | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| ARTHRITIS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| HAEMANGIOMA | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | View |
| HISTIOCYTOSIS | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | View |
| ALTERED STATE OF CONSCIOUSNESS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| FEBRILE CONVULSION | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| HYDROCEPHALUS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| INFANTILE SPASMS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| SEIZURE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| NEONATAL DISORDER | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (19.1) | View |
| POOR WEIGHT GAIN NEONATAL | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (19.1) | View |
| APATHY | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.1) | View |
| RESTLESSNESS | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.1) | View |
| RENAL DISORDER | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.1) | View |
| ACUTE RESPIRATORY DISTRESS SYNDROME | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| ACUTE RESPIRATORY FAILURE | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| APNOEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| APPARENT LIFE THREATENING EVENT | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| ASPIRATION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| ASTHMA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| BRONCHIAL HYPERREACTIVITY | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| BRONCHIAL OBSTRUCTION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| BRONCHITIS CHRONIC | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| BRONCHOPULMONARY DYSPLASIA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| COUGH | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| DYSPNOEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| HYPERCAPNIA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| HYPOXIA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| INFANTILE APNOEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| IRREGULAR BREATHING | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| LARYNGEAL STENOSIS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| NEONATAL HYPOXIA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| OBSTRUCTIVE AIRWAYS DISORDER | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| PNEUMONIA ASPIRATION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| PULMONARY HYPERTENSION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| RALES | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| RESPIRATORY DISORDER | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| RESPIRATORY DISTRESS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| RESPIRATORY FAILURE | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| SLEEP APNOEA SYNDROME | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| TACHYPNOEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| ECZEMA INFANTILE | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| HYPERHIDROSIS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| RASH | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| CARDIAC OPERATION | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (19.1) | View |
| ELECTIVE PROCEDURE | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (19.1) | View |
| ENTEROSTOMY | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (19.1) | View |
| HERNIA REPAIR | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (19.1) | View |
| HOSPITALISATION | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (19.1) | View |
| ILEOSTOMY CLOSURE | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (19.1) | View |
| IMMUNISATION | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (19.1) | View |
| OXYGEN SUPPLEMENTATION | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (19.1) | View |
| PHARYNGEAL RECONSTRUCTION | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (19.1) | View |
| PLASTIC SURGERY OF THE LIPS AND MOUTH | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (19.1) | View |
| PULMONARY VALVE REPAIR | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (19.1) | View |
| AORTIC STENOSIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| THROMBOCYTOPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.1) | View |
| CARDIOVASCULAR DISORDER | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| CYANOSIS | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| HEART DISEASE CONGENITAL | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (19.1) | View |
| DIARRHOEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| VOMITING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| ADMINISTRATION SITE REACTION | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| ADVERSE DRUG REACTION | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| ADVERSE EVENT | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| DRUG INEFFECTIVE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| IRRITABILITY POSTVACCINAL | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| PERIPHERAL SWELLING | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| PYREXIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| VACCINATION SITE REACTION | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| BRONCHITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| BRUCELLOSIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| RESPIRATORY SYNCYTIAL VIRUS BRONCHITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| RESPIRATORY SYNCYTIAL VIRUS INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| UPPER RESPIRATORY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| VIRAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| OVERDOSE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| VACCINATION COMPLICATION | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| DECREASED APPETITE | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| DIET REFUSAL | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| FEEDING DISORDER | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| CONFUSIONAL STATE | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.1) | View |
| PERSONALITY CHANGE | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.1) | View |
| RESTLESSNESS | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.1) | View |
| SCREAMING | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.1) | View |
| BRONCHIAL OBSTRUCTION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| DYSPNOEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| ERYTHEMA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| RASH | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| HOSPITALISATION | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (19.1) | View |