Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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: NCT01350102
Description: None
Frequency Threshold: 0
Time Frame: enrollment through 20 weeks
Study: NCT01350102
Study Brief: The Relationship of Hemoglobin A1c and Diabetic Wound Healing
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bacitracin Wound Care Dressing Alone Bacitracin wound care dressing alone Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing 0 None 0 0 0 0 View
Bacitracin With Vit C Bacitracin wound care dressing with Vitamin C supplementation Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing Vitamin C: Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve 0 None 0 1 0 1 View
AmeriGel® Wound Care Dressing Alone AmeriGel® wound care dressing alone AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing 0 None 0 1 1 1 View
AmeriGel® With Vit C AmeriGel® wound care dressing with Vitamin C supplementation AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing Vitamin C: Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View