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 @ 5:08 AM
Ignite Modification Date: 2025-12-26 @ 4:12 AM
NCT ID: NCT03161327
Description: Adverse Even (AE) any adverse event occurring at the time of or following time of procedure/ embolization through the remainder of study. Serious Adverse Event (SAE): * death during the period of protocol defined surveillance * persistent or significant disability/incapacity. Unanticipated Adverse Event (UAE): any event that could not be reasonably foreseen or had not been previously reported in the product package insert as a potential adverse event related to use of this device
Frequency Threshold: 0
Time Frame: Data was collected over the time of performing the non invasive ABI test. This was for 2 months
Study: NCT03161327
Study Brief: Digital Ankle Brachial Index (ABI) as a Screening Tool in Detecting Peripheral Arterial Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ABIABI Using QuantaFlo™ ABI will be performed in patient ABI using QuantaFlo™: Perform Digital ABI: * Will be performed by the nurse/medical assistant with training to perform this test * The patient will be placed in the supine position, with the arms and legs at the same level as the heart, for a minimum of 5 minutes before measurement. * The optical sensor (similar to a pulse oximeter) will be placed sequentially in the fingers of the hands and feet: Right and left hand fingers and then right and left feet toes. * Usually each digit takes about 15 seconds to obtain a waveform * At the end of 60 seconds, an automated digital ABI will be generated. Clinical course: If based on Screening questionnaire and digital ABI, I. Patient is diagnosed with PAD- the referring physician and patient will receive a phone call about the same. He/ she will then be advised any further testing/ referral to IR clinic. II. There is no evidence of PAD- no further action will be taken. The patient will be informed 0 None 0 238 0 238 View
Serious Events(If Any):
Other Events(If Any):