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 @ 2:44 AM
Ignite Modification Date: 2025-12-26 @ 1:23 AM
NCT ID: NCT04040933
Description: Safety analysis population includes all participants who have IP applied at least once. As planned, adverse events were collected only on the whole participant level.
Frequency Threshold: 0
Time Frame: Up to Day 28
Study: NCT04040933
Study Brief: A Study to Assess Wound Healing Efficacies of Different Adhesive Bandages
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Randomized Participants All Participants with Fitzpatrick skin types II (burns easily; tans minimum)-III (burns moderately; tans gradually) with uniform skin color on forearms, minor wounds were created on forearms (four per arm) by a certified laser specialist received all eight intervention at the same time on the wounds created on forearms. Each wound site was subjected to one of eight randomly-assigned treatments included in an adhesive bandage that were: 1) a marketed adhesive bandage, 2) a marketed adhesive bandage (IP-benchmark control 1), 3) a non-marketed adhesive bandage (IP-benchmark control 2), 4-7) four non-marketed adhesive bandages (IP#1, IP#2, IP#3, IP#4), and 8) no treatment (uncovered, negative control). Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandages were not left on after a composite healing score of 8 was achieved. 0 None 0 36 34 36 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Blister NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Skin abrasion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Thermal burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Animal scratch NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Arthropod bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View