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 @ 4:03 AM
Ignite Modification Date: 2025-12-26 @ 2:58 AM
NCT ID: NCT00167102
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00167102
Study Brief: Alefacept in Patients With Severe Scalp Alopecia Areata
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Alefacept Weekly IM administration of placebo or 15 mg of alefacept for 12 weeks. None None 1 23 20 23 View
Placebo Weekly IM administration of placebo or 15 mg of alefacept for 12 weeks. None None 2 22 9 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Asthma exacerbation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
vomiting and dehydration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
right elbow arthropathy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Cold NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Headaches NON_SYSTEMATIC_ASSESSMENT General disorders MedRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View