Adverse Events Module

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Adverse Events Module

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

Adverse Events Module path is as follows:

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

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

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

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 2:24 PM
Ignite Modification Date: 2025-12-25 @ 12:59 PM
NCT ID: NCT00560859
Description: None
Frequency Threshold: 0
Time Frame: Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
Study: NCT00560859
Study Brief: Childhood Adenotonsillectomy Study for Children With OSAS
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Early AT Surgery Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit. Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome. None None 7 226 166 226 View
Watchful Waiting Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period. Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period. None None 9 227 227 227 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Application site pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pleural Effusion (non-malignant) NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tonsillar haemorrhage NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypersomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Vomitting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Adenoviral upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Allergic cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Allergic rhinitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Allergy to sting NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Animal Bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ankle Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Application site bleeding NON_SYSTEMATIC_ASSESSMENT General disorders None View
Application site rash NON_SYSTEMATIC_ASSESSMENT General disorders None View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Asthmatic crisis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Attention Deficit/Hyperactivitiy disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Bacterial infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Blood Glucose NON_SYSTEMATIC_ASSESSMENT Investigations None View
Body Tinea NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Breath Odor NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Choking sensation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Conjuctivits NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Croup Infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Croup Non infectious NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diabetes Mellitus non-insulin dependent NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ear Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ear Infection Baceterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ear Pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Ear Piercing NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Ear Tube removal NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
electroencephalogram abnormal NON_SYSTEMATIC_ASSESSMENT Investigations None View
Emergency care examination normal NON_SYSTEMATIC_ASSESSMENT Investigations None View
Enuresis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
External ear infection NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Eye Allergy NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Febrile infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
fever (in the absence of neutropenia, where neutropenia is defined as anc <1.0 x 10e9/l) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Finger nail removal NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Foreign body in eye NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fungal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis adenovirus NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
genital rash NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Growing pains NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
hand fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hand-foot-and-mouth disease NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
head injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Heart rate irregular NON_SYSTEMATIC_ASSESSMENT Investigations None View
hordeolum NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
hypersomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
incision site pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
infected insect bite NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
infection with unknown anc - bladder (urinary) NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders None View
laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Lice infestation NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
loss of consciousness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
multiple allergies NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
muscle injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Nail Tinea NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
nasal cavity/paranasal sinus reactions NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis media bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
pain management NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
pharyngitis streptococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
pneumonia mycoplasmal NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
post procedural complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
postnasal drip NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
postoperative fever NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
precocious puberty NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
productive cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pulmonary congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
relapsing fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rhinitis seasonal NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinovirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
road traffic accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Scarlet Fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Seasonal Allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Sinus congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinus headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Sleep Apnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Snoring NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Staphylococcal skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Stomach discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Streptococcal bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Streptococcal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sweating fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Throat irritation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tinea infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tongue Tie operation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Tonsillar haemorrhage NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tonsillitis streptococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tooth Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Torticollis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Tympanometry NON_SYSTEMATIC_ASSESSMENT Investigations None View
Upper respiratory tract congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract inflammation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract pain NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Varicella NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
vasomotor rhinitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Viral Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral Rash NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral Upper Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomitting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wrist fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View