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 @ 6:59 PM
Ignite Modification Date: 2025-12-25 @ 4:32 PM
NCT ID: NCT02667457
Description: Analysis was performed in the safety population defined as all participants who received the administration of 99mTc-rhAnnexin V-128.
Frequency Threshold: 0
Time Frame: Adverse events were collected from Day 0 up to Day 30
Study: NCT02667457
Study Brief: 99mTc-rhAnnexin V-128 Imaging for Carotid Atherosclerosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CAD Participants Participants with asymptomatic carotid atherosclerotic plaque or previously symptomatic with TIA only with evidence of 50% or more carotid stenosis in one or more carotid arteries on carotid ultrasound within 2 years, received a single intravenous bolus of 350 MBq ± 10 % of 99mTc-rhAnnexin V-128 via an IV catheter in an antecubital vein, followed by a saline flush on screening (Day 0). 0 None 1 26 7 26 View
Healthy Participants Healthy participants with no significant carotid artery disease on carotid ultrasound, received a single intravenous bolus of 350 MBq ± 10 % of 99mTc-rhAnnexin V-128 via an IV catheter in an antecubital vein, followed by a saline flush on screening (Day 0). 0 None 0 10 0 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version: 19.0 View
Accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version: 19.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version: 19.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version: 19.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version: 19.0 View
Claustrophobia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version: 19.0 View
Sinus headache SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version: 19.0 View