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 @ 3:49 PM
Ignite Modification Date: 2025-12-25 @ 1:56 PM
NCT ID: NCT04445792
Description: Per the study protocol, only Adverse Device Effect (ADE) events suspected to be related to the specimen collection, laboratory assay genotyping results, and phenoconversion recommendations from the Best Practice Alerts (BPAs)/Consult notes were reported to the IRB. Reportable ADEs or unanticipated Adverse Device Effect (UADEs) events including unanticipated study related deaths will be collected in the study database per IRB reporting policies. Medication side effects were not included as AEs.
Frequency Threshold: 0
Time Frame: Approximately 6 months
Study: NCT04445792
Study Brief: A Depression and Opioid Pragmatic Trial in Pharmacogenetics (DCRI Coordinating Center)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Immediate Pharmacogenetics (PGx) Guided Therapy Acute Pain Trial: Immediate pharmacogenetic testing and genotype-guided post-surgical opioid therapy (Intervention arm). Chronic Pain Trial: Immediate pharmacogenetic testing and genotype-guided opioid therapy (Intervention arm). Depression: Immediate pharmacogenetic testing and genotype-guided anti-depressant therapy (Intervention arm). 5 None 0 2550 1 2550 View
Delayed Pharmacogenetics (PGx) Testing Acute Pain Trial: Standard care and pharmacogenetic testing after 6 months (Control arm). Chronic Pain Trial: Standard care with 6-month delayed pharmacogenetic testing (Control arm). Depression: Standard care with 6-month delayed pharmacogenetic testing (Control arm). 7 None 0 2550 0 2550 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Panic Attack due to sample blood draw NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View