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 @ 7:38 PM
Ignite Modification Date: 2025-12-25 @ 5:19 PM
NCT ID: NCT03138603
Description: None
Frequency Threshold: 0
Time Frame: Adverse events (AEs) were collected and assessed during study phase participation, e.g., intervention administration, and daily post-operative follow-up, up to 30-days post-operative.
Study: NCT03138603
Study Brief: Metoprolol to Reduce Perioperative Myocardial Injury
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Metoprolol Metoprolol group, 3-intravenous doses of 5mg metoprolol tartrate (over 15-minutes), and oral dose(s) of 25mg metoprolol approximately every 8 hours postoperatively for up to 3-days (or 72 hrs). Metoprolol Tartrate: Patients will be randomly assigned to receive up-to-three intravenous doses of 5mg metoprolol tartrate (over 15-minutes) at the end of their surgical procedure, and a scheduled oral dose regimen of 25mg metoprolol approximately every 8-hours postoperatively for up to 3-days (or 72 hrs). Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized metoprolol group. 0 None 0 34 8 34 View
Placebo Placebo comparator group, up-to-three intravenous doses of placebo comparator (over 15-minutes), and oral dose(s) of a placebo comparator approximately every 8 hours postoperatively for up to 3-days (or 72 hrs). Placebo: Patients will be randomly assigned to receive up-to-three intravenous doses of a placebo-comparator (over 15-minutes) at the end of their surgical procedure, and scheduled oral dose regimen of a placebo-comparator approximately every 8-hours postoperatively for up to 3-days (or 72 hrs). Post-operative analysis to determine Myocardial Injury (hs-cTnT) in randomized placebo group. 0 None 0 38 3 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
MACE events NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypotension event NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bradycardia Event NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View