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 @ 12:46 PM
Ignite Modification Date: 2025-12-25 @ 12:14 PM
NCT ID: NCT04881461
Description: All AEs starting on/after time of first IMP administration and no later than 7 days after last IMP administration are displayed. Both treatment-related and non-treatment-related AEs are displayed.
Frequency Threshold: 5
Time Frame: Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (approximately 26 months of treatment). The displayed AEs were collected starting on/after time of first IMP administration and no later than 7 days after last IMP administration.
Study: NCT04881461
Study Brief: A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed 0 None 6 223 111 223 View
5-grass Mix SLIT-drops Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed 0 None 4 222 128 222 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.1 View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Lumbar vertebral fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.1 View
Breast cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.1 View
Ovarian cyst ruptured NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23.1 View
Choking NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
Device breakage NON_SYSTEMATIC_ASSESSMENT Product Issues MedDRA 23.1 View
Varicose vein NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.1 View
Gastrointestinal procedural complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.1 View
Wrist fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Oral pruritus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
Oral discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
Mouth swelling NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
Throat irritation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View