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 @ 3:54 AM
Ignite Modification Date: 2025-12-26 @ 2:44 AM
NCT ID: NCT05009602
Description: An AE is any untoward medical occurrence in a patient or clinical trial participant. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, whether or not considered related to the trial protocol. For the purposes of the study, only AEs related to study procedures were recorded.
Frequency Threshold: 0
Time Frame: Reported during the study duration; approximately 6 weeks (from baseline until scan performed).
Study: NCT05009602
Study Brief: Diagnostic Tools to Establish the Presence and Severity of Peripheral Arterial Disease in People With Diabetes
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 Participants Diagnostic Test: Toe Brachial Pressure Index (TBPI) TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger. Diagnostic Test: Ankle Brachial Pressure Index (ABPI) A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery. Diagnostic Test: Exercise Ankle Brachial Pressure Index (ABPI) A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery, following the participant completing 50 consecutive repetitions of active dorsiflexion whilst standing. Diagnostic Test: Audible handheld Doppler Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery. Diagnostic Test: Visual handheld Doppler Visual CW interrogation of the dorsalis pedis and posterior tibial artery was performed using the handheld Huntleigh Digital Dopplex device. Diagnostic Test: Podiatry Ankle Duplex scan (PAD-scan) Podiatry ankle duplex scan (PAD-scan) involves using an ultrasound machine to visualise the anterior and posterior tibial arteries at the ankle. To be used in 3 participating centers only. 1 None 0 604 4 604 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cramp and leg pain NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Leg pain NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Bilateral Leg pain NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View