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 @ 2:11 PM
Ignite Modification Date: 2025-12-24 @ 2:11 PM
NCT ID: NCT00465595
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00465595
Study Brief: Psychopharmacology of Psilocybin in Cancer Patients
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 Condition (Group) The experimental design of this study is a complete cross-over, with two groups of participants receiving the low and high doses of psilocybin in counterbalance order. The Low Dose Group is comprised of all low dose psilocybin sessions (n=50). The number of sessions is different from the total enrollment because of dropouts. None None 0 56 10 56 View
High Dose Condition (Group) The experimental design of this study is a complete cross-over, with two groups of participants receiving the low and high doses of psilocybin in counterbalance order. The High Dose Group is comprised of all high dose psilocybin sessions (n=50). The number of sessions is different from the total enrollment because of dropouts. None None 0 56 23 56 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Elevated Systolic Blood Pressure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Elevated Diastolic Blood Pressure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Anxiety Episode None Psychiatric disorders None View