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 @ 10:33 PM
Ignite Modification Date: 2025-12-25 @ 8:06 PM
NCT ID: NCT02063035
Description: Participants were monitored only for the following serious adverse events from time of admission to hospital for surgery up to study completion: myocardial infarction, stroke, thrombosis, and postoperative infection. Non-serious adverse events were not collected in this study.
Frequency Threshold: 0
Time Frame: From time of admission to hospital for surgery up to study completion (up to approximately 2.5 years).
Study: NCT02063035
Study Brief: Effectiveness Study of the Drug Tranexamic Acid to Reduce Post-surgery Blood Loss in Spinal Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tranexamic Acid Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated. None None 3 12 0 0 View
Placebo Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated. None None 1 17 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial infaction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Postoperative wound infection after release from hospital SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):