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: 2025-12-24 @ 10:41 PM
Ignite Modification Date: 2025-12-25 @ 8:11 PM
NCT ID: NCT01253135
Description: All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
Frequency Threshold: 3
Time Frame: Safety reporting occurred over the three weeks of the treatment period.
Study: NCT01253135
Study Brief: Study to Determine if Fibrin Affects the Ability of a Wound to Heal
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control White Petrolatum White Petrolatum: Topical application White petrolatum was applied daily to the appropriate wound. None None 0 40 18 40 View
Test Article 802-247 Vehicle (fibrinogen) Fibrin: Topical application of fibrinogen spray, followed by thrombin spray HP802-247 Vehicle (260 µL) was applied to the appropriate wound on days 1, 8, and 15. White petrolatum was applied daily. On days 1, 8,and 15 it was applied 5 min after application of HP802-247 Vehicle, to allow the fibrin matrix to mature. None None 0 40 18 40 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Musculoskeletal & connective tissue disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v 12.0 View
Skin & subcutaneous tissue disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v 12.0 View
General disorders & administrative site conditions SYSTEMATIC_ASSESSMENT General disorders MedDRA v 12.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA v 12.0 View
Infections and Infestations SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v 12.0 View
Injury, poisoning & procedural complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v 12.0 View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v 12.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v 12.0 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v 12.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v 12.0 View