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 @ 6:38 PM
Ignite Modification Date: 2025-12-25 @ 4:09 PM
NCT ID: NCT03531957
Description: None
Frequency Threshold: 5
Time Frame: 1 year, 1 month
Study: NCT03531957
Study Brief: Phase 2B Study to Evaluate ASN002 in Subjects With Moderate to Severe Atopic Dermatitis (RADIANT)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ASN002 40 mg 40 mg ASN002 ASN002: Daily dose of ASN002 for 12 weeks 0 None 4 61 20 61 View
ASN002 60 mg 60 mg ASN002 ASN002: Daily dose of ASN002 for 12 weeks 0 None 0 59 19 59 View
ASN002 80 mg 80 mg ASN002 ASN002: Daily dose of ASN002 for 12 weeks 0 None 2 63 24 63 View
Placebo Oral Tablet Matching placebo for ASN002 doses Placebo Oral Tablet: Placebo of ASN002 for 12 weeks 0 None 0 60 9 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
dysarthria NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
staphylococcal bacteremia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (21.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View