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 @ 5:06 PM
Ignite Modification Date: 2025-12-25 @ 2:45 PM
NCT ID: NCT00550550
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00550550
Study Brief: Efficacy and Safety of Grass Sublingual Tablet in Children and Adolescents (P05239 AM3)(COMPLETED)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SCH 697243 Rapidly dissolving grass pollen allergen tablet administered sublingually once daily. None None 0 176 141 176 View
Placebo Rapidly dissolving matching placebo tablet administered sublingually once daily. None None 4 169 121 169 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaesthetic complications None Injury, poisoning and procedural complications None View
Idiopathic thromnocytopenic purpura None Blood and lymphatic system disorders None View
Lymphadenitis None Blood and lymphatic system disorders None View
Pyelonephritis None Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear pruritus None Ear and labyrinth disorders None View
Eye pruritis None Eye disorders None View
Abdominal pain upper None Gastrointestinal disorders None View
Lip swelling None Gastrointestinal disorders None View
Oedema mouth None Gastrointestinal disorders None View
Oral pruritis None Gastrointestinal disorders None View
Stomatitis None Gastrointestinal disorders None View
Pyrexia None General disorders None View
Gastroenteritis viral None Infections and infestations None View
Influenza None Infections and infestations None View
Nasopharyngitis None Infections and infestations None View
Sinusitis None Infections and infestations None View
Upper respiratory tract infection None Infections and infestations None View
Viral upper respiratory tract infection None Infections and infestations None View
Headache None Nervous system disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Epistaxis None Respiratory, thoracic and mediastinal disorders None View
Nasal congestion None Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal pain None Respiratory, thoracic and mediastinal disorders None View
Pharyngeal erythema None Respiratory, thoracic and mediastinal disorders None View
Sneezing None Respiratory, thoracic and mediastinal disorders None View
Throat irritation None Respiratory, thoracic and mediastinal disorders None View
Uticaria None Skin and subcutaneous tissue disorders None View