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: 2025-12-25 @ 2:45 AM
Ignite Modification Date: 2025-12-26 @ 1:25 AM
NCT ID: NCT01199133
Description: Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period. A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
Frequency Threshold: 5
Time Frame: Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months.
Study: NCT01199133
Study Brief: Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis in Adolescents and 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
300 IR 300 IR house dust mites allergen extract tablet None None 8 241 149 241 View
Placebo Placebo tablet None None 7 230 124 230 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 12.1. View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 12.1. View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 12.1. View
Ligament injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 12.1. View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 12.1. View
Status asthmaticus SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 12.1. View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 12.1. View
Gastroenteritis salmonella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 12.1. View
Umbilical hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 12.1. View
Abortion induced SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA version 12.1. View
Adjustment disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 12.1. View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 12.1. View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 12.1. View
Varicocele SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA version 12.1. View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 12.1. View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 12.1. View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 12.1. View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 12.1. View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 12.1. View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 12.1. View
Oral pruritus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 12.1. View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 12.1. View
Tooth loss SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 12.1. View
Tongue oedema SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 12.1. View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 12.1. View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 12.1. View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 12.1. View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 12.1. View