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 @ 7:57 PM
Ignite Modification Date: 2025-12-25 @ 5:31 PM
NCT ID: NCT04541004
Description: An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP. An AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.
Frequency Threshold: 2
Time Frame: AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).
Study: NCT04541004
Study Brief: Adolescent Mite Allergy Safety Evaluation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
HDM SLIT Tablet House dust mite (HDM) Sublingual allergy immunotherapy tablet HDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day) 0 None 0 253 223 253 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Glossodynia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Mouth ulceration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Pharyngeal paraesthesia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pharyngeal swelling NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Throat irritation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Ear pruritus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Enlarged uvula NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Lip oedema NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Lip swelling NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Mouth swelling NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Oedema mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Oral pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Oral pruritus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Swollen tongue NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Tongue eruption NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Tongue ulceration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View