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 @ 4:41 AM
Ignite Modification Date: 2025-12-26 @ 3:43 AM
NCT ID: NCT02781818
Description: Adverse event collections was done by phone on or about day 14 following the study intervention.
Frequency Threshold: 0
Time Frame: 14 days
Study: NCT02781818
Study Brief: A Randomized Controlled Trial Evaluating the Efficacy of Intralesional Triamcinolone in Hidradenitis Suppurativa.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Triamcinolone Acetonide 10mg/mL Each lesion randomized to this group will receive a single intralesional treatment with 0.1mL of triamcinolone 10mg/mL solution. Triamcinolone Acetonide 10mg/mL: Triamcinolone acetonide is a glucocorticoid used in intralesional treatment of many skin diseases, intra-articular treatment of inflammatory joint diseases, and intramuscular treatment for systemic management of systemic inflammatory diseases. It is commonly used in clinical practice for the treatment of acute abscesses and nodules of hidradenitis suppurativa, but little clinical trial data exist supporting its use. 0 None 0 20 0 20 View
Triamcinolone Acetonide 40mg/mL Each lesion randomized to this group will receive a single intralesional treatment with 0.1mL of triamcinolone 40mg/mL solution. Triamcinolone Acetonide 40mg/mL: Triamcinolone acetonide is a glucocorticoid used in intralesional treatment of many skin diseases, intra-articular treatment of inflammatory joint diseases, and intramuscular treatment for systemic management of systemic inflammatory diseases. It is commonly used in clinical practice for the treatment of acute abscesses and nodules of hidradenitis suppurativa, but little clinical trial data exist supporting its use. 0 None 0 18 0 18 View
Normal Saline Placebo Each lesion randomized to this group will receive a single intralesional treatment with 0.1mL of sterile normal saline solution. Normal Saline: Normal saline 0.1mL will be administered intralesionally at the selected site. 0 None 0 17 0 17 View
Serious Events(If Any):
Other Events(If Any):