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 @ 4:01 PM
Ignite Modification Date: 2025-12-25 @ 2:04 PM
NCT ID: NCT05442866
Description: Adverse events were first collected by the study coordinator during usual study processes and participant follow up and were each reviewed by the PI.
Frequency Threshold: 0
Time Frame: Each participant was enrolled and followed by the study coordinator for a maximum period of 3 weeks (from enrollment and baseline measures to final measure collection). Because virtual reality has never been shown to have adverse events that last longer than the duration of the virtual reality device use, this time frame was most appropriate for adverse event data collection.
Study: NCT05442866
Study Brief: Virtual Reality for Outpatient Cancer Pain Management
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Virtual Reality (VR) Dosing Arm All participants will proceed in this single arm, in which each participant will complete baseline measures, then receive 1 week of VR daily for 10 minutes per session, then 1 week of VR twice a day for 10 minutes per session, then 1 week of VR use as desired by the participant. Virtual reality experience for 10 minutes: Each 10-minute VR session will be self-administered (by each participant) using the Facebook (Facebook Inc., Menlo Park, CA) Meta Quest 2 VR and Touch controllers. This equipment was selected because it is portable, has built in audio, and has clear graphics at a lower price than VR setups that require a computer to generate graphics. The headset has an optional eyeglass spacer to allow participants to wear corrective eyeglasses during the VR session if appropriate. The hand controllers facilitate immersive, interactive VR experiences. The VR software, Nature Treks VR application (https://naturetreksvr.com) that features ten non-violent, nature-based experiences in peaceful environments (e.g. forest, river, beach, etc.) that can be played in a seated or fixed position. 1 None 2 33 2 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Surgery NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Hospitalized NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View