Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 4:19 PM
Ignite Modification Date: 2025-12-25 @ 2:16 PM
NCT ID: NCT00129766
Description: None
Frequency Threshold: 1
Time Frame: Day 0 - Day 150
Study: NCT00129766
Study Brief: Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children
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 Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses None None 506 3298 2777 3298 View
Motavizumab Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses None None 485 3315 2784 3315 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
PNEUMONIA VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
POSTOPERATIVE WOUND INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
PYELONEPHRITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
PYELONEPHRITIS ACUTE SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
RESPIRATORY SYNCYTIAL VIRUS INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
RESPIRATORY TRACT INFECTION VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
RHINITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
ROTAVIRUS INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
STAPHYLOCOCCAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
TRACHEITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
TRACHEOBRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
URINARY TRACT INFECTION BACTERIAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
URINARY TRACT INFECTION ENTEROCOCCAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
URINARY TRACT INFECTION PSEUDOMONAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
UROSEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
VARICELLA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
VIRAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
VIRAL RHINITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
VIRAL UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
WOUND INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
CHILD MALTREATMENT SYNDROME SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
DEVICE MALFUNCTION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
FACE INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
FEEDING TUBE COMPLICATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
FOREIGN BODY TRAUMA SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
HAIR-THREAD TOURNIQUET SYNDROME SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
HEAD INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
MEDICAL DEVICE COMPLICATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
POST PROCEDURAL DISCHARGE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
SHUNT MALFUNCTION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
SKULL FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
SUBDURAL HAEMATOMA SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
TRAUMATIC BRAIN INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
VENTRICULOPERITONEAL SHUNT MALFUNCTION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
VIIITH NERVE INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
BIOPSY RECTUM SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
BLOOD BILIRUBIN INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
CYSTOGRAM SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
FALSE POSITIVE LABORATORY RESULT SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
HEPATIC ENZYME INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
INVESTIGATION SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
LIVER FUNCTION TEST ABNORMAL SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
MEDICAL OBSERVATION SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
NEUROLOGICAL EXAMINATION SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
OESOPHAGEAL PH SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
OXYGEN SATURATION DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
PHYSICAL EXAMINATION SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
WEIGHT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
ANOREXIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
COW'S MILK INTOLERANCE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
FAILURE TO THRIVE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
FEEDING DISORDER OF INFANCY OR EARLY CHILDHOOD SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
FLUID INTAKE REDUCED SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
FLUID OVERLOAD SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
HYPERCALCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
HYPERNATRAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
LACTOSE INTOLERANCE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
MALNUTRITION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
WEIGHT GAIN POOR SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
ZINC DEFICIENCY SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
CRANIOSYNOSTOSIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
MUSCLE CONTRACTURE SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
OSTEOPENIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
HAEMANGIOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.1 View
ALTERED STATE OF CONSCIOUSNESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
CEREBRAL VENTRICLE DILATATION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
CONVULSION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
CONVULSION NEONATAL SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
ENCEPHALITIS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
EPILEPSY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
FEBRILE CONVULSION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
HAEMORRHAGE INTRACRANIAL SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
HYDROCEPHALUS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
HYPERTONIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
HYPOXIC ENCEPHALOPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
INTRACRANIAL PRESSURE INCREASED SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
LETHARGY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
MYOCLONUS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
SOMNOLENCE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
SYNCOPE VASOVAGAL SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
VOCAL CORD PARESIS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
BREATH HOLDING SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
RESTLESSNESS SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
URETERIC STENOSIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.1 View
BALANITIS SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.1 View
OVARIAN CYST SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.1 View
SCROTAL OEDEMA SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.1 View
APNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
APPARENT LIFE THREATENING EVENT SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
ASPIRATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
ASTHMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
ATELECTASIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
BRONCHIAL HYPERREACTIVITY SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
BRONCHOPNEUMOPATHY SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
BRONCHOPULMONARY DYSPLASIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
BRONCHOSPASM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
CHOKING SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
FOREIGN BODY ASPIRATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
HYPOVENTILATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
HYPOXIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
INTERSTITIAL LUNG DISEASE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
LARYNGEAL OEDEMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
LARYNGEAL STENOSIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
LARYNGOSPASM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
LUNG CONSOLIDATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
NASAL CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
OBSTRUCTIVE AIRWAYS DISORDER SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
PHARYNGEAL INFLAMMATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
PNEUMONIA ASPIRATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
PNEUMOTHORAX SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
PULMONARY CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
PULMONARY HAEMORRHAGE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
PULMONARY HYPERTENSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
PULMONARY HYPERTENSIVE CRISIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
PULMONARY OEDEMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
RESPIRATORY DISORDER SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
RESPIRATORY DISTRESS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
RESPIRATORY FAILURE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
SLEEP APNOEA SYNDROME SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
STATUS ASTHMATICUS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
STRIDOR SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
TACHYPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
TONSILLAR HYPERTROPHY SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
VOCAL CORD DISORDER SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
WHEEZING SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
ANGIOEDEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
PETECHIAE SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
URTICARIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
SOCIAL STAY HOSPITALISATION SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 11.1 View
VICTIM OF CHILD ABUSE SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 11.1 View
CENTRAL VENOUS CATHETERISATION SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 11.1 View
COLOSTOMY CLOSURE SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 11.1 View
EAR TUBE INSERTION SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 11.1 View
GASTROSTOMY CLOSURE SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 11.1 View
GASTROSTOMY TUBE INSERTION SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 11.1 View
ILEOSTOMY CLOSURE SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 11.1 View
NUTRITIONAL SUPPORT SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 11.1 View
VENTRICULO-PERITONEAL SHUNT SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 11.1 View
HAEMORRHAGE SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.1 View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.1 View
CARDIAC ARREST SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
CARDIAC FAILURE HIGH OUTPUT SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
CARDIO-RESPIRATORY ARREST SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
CARDIOGENIC SHOCK SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
CYANOSIS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
SUPRAVENTRICULAR TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
ACRODERMATITIS ENTEROPATHICA SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.1 View
ANAL ATRESIA SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.1 View
ANKYLOGLOSSIA CONGENITAL SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.1 View
BRANCHIAL CLEFT CYST SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.1 View
CEREBRAL PALSY SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.1 View
CLEFT LIP SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.1 View
CLEFT LIP AND PALATE SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.1 View
CLEFT PALATE SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.1 View
DACRYOSTENOSIS CONGENITAL SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.1 View
DERMOID CYST SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.1 View
HAMARTOMA SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.1 View
HIP DYSPLASIA SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.1 View
LIMB REDUCTION DEFECT SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.1 View
PHIMOSIS SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.1 View
PILONIDAL CYST CONGENITAL SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.1 View
PYLORIC STENOSIS SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.1 View
RESPIRATORY TRACT MALFORMATION SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.1 View
SYNDACTYLY SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.1 View
TALIPES SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.1 View
TRACHEO-OESOPHAGEAL FISTULA SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.1 View
VENTRICULAR SEPTAL DEFECT SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.1 View
DEAFNESS SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 11.1 View
PAPILLOEDEMA SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.1 View
RETINOPATHY OF PREMATURITY SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.1 View
RETINOPATHY PROLIFERATIVE SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.1 View
ABDOMINAL DISTENSION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
ABDOMINAL STRANGULATED HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
ANAL FISTULA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
COLONIC STENOSIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
DYSPHAGIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
ENTERITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
ENTEROCOLITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
ENTEROCUTANEOUS FISTULA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
FAECES DISCOLOURED SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
FLATULENCE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
GASTROINTESTINAL DISORDER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
GASTROINTESTINAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
GASTROOESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
HIATUS HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
ILEUS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
INGUINAL HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
INGUINAL HERNIA, OBSTRUCTIVE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
INTUSSUSCEPTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
NECROTISING COLITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
OESOPHAGEAL MASS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
PANCREATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
RECTAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
REFLUX OESOPHAGITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
REGURGITATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
UMBILICAL HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
FEVER NEONATAL SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
HERNIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
HERNIA OBSTRUCTIVE SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
HYPOTHERMIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
MALAISE SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
SUDDEN DEATH SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
SUDDEN INFANT DEATH SYNDROME SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
CHOLELITHIASIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.1 View
CHOLESTASIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.1 View
HEPATIC CYST SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.1 View
HYPERBILIRUBINAEMIA SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.1 View
DRUG HYPERSENSITIVITY SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 11.1 View
HYPERSENSITIVITY SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 11.1 View
IMMUNISATION REACTION SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 11.1 View
ABSCESS LIMB SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
ABSCESS NECK SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
ADENOVIRAL UPPER RESPIRATORY INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
BACTERAEMIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
BACTERIAL ABSCESS CENTRAL NERVOUS SYSTEM SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
BACTERIAL PYELONEPHRITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
BACTERIAL TRACHEITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
BRONCHIOLITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
BRONCHITIS VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
BRONCHOPNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
CATHETER SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
CENTRAL LINE INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
CLOSTRIDIAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
CROUP INFECTIOUS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
CYTOMEGALOVIRUS INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
DACRYOCYSTITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
DYSENTERY SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
ENTEROBACTER BACTERAEMIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
ENTEROCOLITIS VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
ESCHERICHIA SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
ESCHERICHIA URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
EXANTHEMA SUBITUM SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
EXTERNAL EAR CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
GASTROENTERITIS ADENOVIRUS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
GASTROENTERITIS ESCHERICHIA COLI SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
LARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
LOBAR PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
LOWER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
LOWER RESPIRATORY TRACT INFECTION VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
LUNG ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
LYMPHADENITIS BACTERIAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
MENINGITIS VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
ORAL CANDIDIASIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
OSTEOMYELITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
OTITIS MEDIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
OTITIS MEDIA BACTERIAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
PARAINFLUENZAE VIRUS INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
PERTUSSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
PHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
PHARYNGOTONSILLITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
PNEUMONIA ADENOVIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
PNEUMONIA BACTERIAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
PNEUMONIA BORDETELLA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
PNEUMONIA INFLUENZAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
PNEUMONIA PARAINFLUENZAE VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
ANAEMIA NEONATAL SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
CYCLIC NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
HAEMOLYTIC ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
HAEMOLYTIC URAEMIC SYNDROME SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
IRON DEFICIENCY ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
ATRIAL THROMBOSIS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
BRADYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
GASTROENTERITIS ROTAVIRUS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
GASTROENTERITIS SALMONELLA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
GASTROENTERITIS VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
HERPES ZOSTER SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
IMPETIGO SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
FLATULENCE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
GASTROOESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
TEETHING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
UMBILICAL HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
INJECTION SITE ERYTHEMA SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
IRRITABILITY SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
BRONCHIOLITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
CANDIDIASIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
IMMUNISATION REACTION SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 11.1 View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
GASTROENTERITIS VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
LOWER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
ORAL CANDIDIASIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
OTITIS MEDIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
OTITIS MEDIA ACUTE SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
PHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
RHINITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
VIRAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
VIRAL UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
BLOOD UREA INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
HAEMANGIOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.1 View
AGITATION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
ASTHMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
BRONCHIAL HYPERREACTIVITY SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
NASAL CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
WHEEZING SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
DERMATITIS ATOPIC SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
DERMATITIS DIAPER SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
DRY SKIN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
ECZEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
SEBORRHOEIC DERMATITIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
CONJUNCTIVITIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.1 View
INJECTION SITE PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
RESPIRATORY DISORDER SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
RHINORRHOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
DACRYOSTENOSIS CONGENITAL SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.1 View