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 @ 9:26 PM
Ignite Modification Date: 2025-12-25 @ 7:11 PM
NCT ID: NCT01797432
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01797432
Study Brief: Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of 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
Combined IL Kenalog and Restylane Injection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10): Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp Restylane: Intralesional injections of 2mLs of Restylane on one side of the scalp 0 None 0 14 11 14 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bronchial Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Shingles None Infections and infestations None View
Bladder Infection None Renal and urinary disorders None View
Migraine Headache None General disorders None View
Cold Sore None Immune system disorders None View
Fatigue None General disorders None View
Allergic Reaction None Immune system disorders None View
Upper Respiratory Infection None Respiratory, thoracic and mediastinal disorders None View
Pain at Injection Site None Skin and subcutaneous tissue disorders None View
Irregular Menstrual Cycle None Reproductive system and breast disorders None View
Cold/flu None Infections and infestations None View
Headache None General disorders None View
Difficulty Concentrating None General disorders None View
Traveler's Diarrhea None Gastrointestinal disorders None View
Acne None Skin and subcutaneous tissue disorders None View
Vomiting None Gastrointestinal disorders None View
Eczema None Skin and subcutaneous tissue disorders None View
Hives None Immune system disorders None View
Bump on Head None Injury, poisoning and procedural complications None View