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: 2025-12-26 @ 10:37 AM
Ignite Modification Date: 2025-12-26 @ 10:37 AM
NCT ID: NCT02643628
Description: None
Frequency Threshold: 0
Time Frame: six (6) months
Study: NCT02643628
Study Brief: A Pilot Study to Evaluate the Safety and Effectiveness of Microneedling and Bellafill to Treat Facial Acne Scars
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Microneedling Followed by Bellafill Treatment Subjects undergo microneedling as described for the Microneedling Only group. Then at Week 12, all eligible scars within the treatment areas on each side of the face will be treated with Bellafill (injected using a standard tunneling technique). A touch-up treatment is allowed at Month 1 after initial treatment, if additional treatment is required to achieve optimal correction. Microneedling followed by Bellafill treatment 0 None 0 23 2 23 View
Microneedling Only All eligible scars within the treatment areas on each side of the face will receive microneedling treatment. The device will be rolled in a horizontal direction with medium pressure. After every roll, the device will be lifted and positioned a few millimeters inferior to the previous starting point. Rolling will be repeated until the entire skin area has been treated. The device will then be reoriented vertically and rolling will be repeated in a vertical direction. Microneedling 0 None 0 21 1 21 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Treatment Site Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Peripheral edema of the foot SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
slight cold SYSTEMATIC_ASSESSMENT Immune system disorders None View