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 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:26 PM
NCT ID:
NCT02626156
Description:
ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB
Frequency Threshold:
0
Time Frame:
Data were collected for each participant for 6 months during study enrollment period.
Study:
NCT02626156
Study Brief:
Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cooling Gel Pack - Venous Leg Ulcer | A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | 1 | None | 4 | 42 | 14 | 42 | View |
| Cooling Cotton Pack - Venous Leg Ulcer | A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | 0 | None | 2 | 40 | 7 | 40 | View |
| Cooling Gel Pack - Diabetic Foot Ulcer | A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | 0 | None | 3 | 29 | 15 | 29 | View |
| Cooling Cotton Pack - Diabetic Foot Ulcer | A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | 0 | None | 4 | 29 | 10 | 29 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Stroke | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Heart attack or failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Shortness of breath | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Fainted | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Amputation | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Renal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| New ulcers | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Recurrent ulcers | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |