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 @ 2:25 AM
Ignite Modification Date: 2025-12-26 @ 12:58 AM
NCT ID: NCT02786134
Description: The adverse definitions match those listed on clincaltrials.gov.
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT02786134
Study Brief: Coronary Flow Reserve to Assess Cardiovascular Inflammation (CIRT-CFR)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Low-Dose Methotrexate (LDM) Patients willing to participate in CIRT will be asked to enroll into the sub-study and may sign the CIRT-CFR informed consent at any point between signing the parent CIRT informed consent and completing the parent CIRT randomization visit (Visit 4). After giving informed consent for the ancillary CIRT-CFR, patients will undergo the baseline rest/dipyridamole stress PET scan along with echocardiography. The final PET scan and echocardiogram will occur at approximately 12 months after randomization. PET scan: A cardiac PET scan will be performed at baseline (main CIRT trial randomization) and at 12-months. Echocardiogram: An echocardiogram will be performed at baseline (main CIRT trial randomization) and at 12-months. 0 None 0 25 4 25 View
Placebo Patients willing to participate in CIRT will be asked to enroll into the sub-study and may sign the CIRT-CFR informed consent at any point between signing the parent CIRT informed consent and completing the parent CIRT randomization visit (Visit 4). After giving informed consent for the ancillary CIRT-CFR, patients will undergo the baseline rest/dypridamole stress PET scan along with echocardiography. The final PET scan and echocardiogram will occur at approximately 12 months after randomization. PET scan: A cardiac PET scan will be performed at baseline (main CIRT trial randomization) and at 12-months. Echocardiogram: An echocardiogram will be performed at baseline (main CIRT trial randomization) and at 12-months. 0 None 0 25 2 25 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Shortness of Breath during PET scan SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Headache during PET scan SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest Pain during PET scan SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Swelling at IV site SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Developed atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View