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 @ 7:32 PM
Ignite Modification Date: 2025-12-25 @ 5:14 PM
NCT ID: NCT06063603
Description: Groups II and III did not participate in the intervention and were not enrolled to the study. Adverse events were not collected from the provider and interventionalist participants in Group II or III.
Frequency Threshold: 0
Time Frame: Up to 60 days
Study: NCT06063603
Study Brief: Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group I (Pain Management) See detailed description. Acupuncture Therapy: Undergo acupuncture therapy Cancer Pain Management: Receive pain clinic referral Cognitive Behavior Therapy: Undergo CBT Educational Intervention: Receive self-guided pain management education materials Exercise: Participate in exercise Interview: Complete interview Massage Therapy: Receive massage Mindfulness Relaxation: Practice mindfulness Pain Therapy: Receive pain treatment/medicine Palliative Therapy: Receive palliative care referral Patient Navigation: Undergo visits with PCM and CHW for pain management Referral: Receive pain management referrals Spiritual Therapy: Receive spiritual support Spiritual Care Referral: Receive spiritual care referral Survey Administration: Ancillary studies 0 None 0 51 0 51 View
Group II (Intervention Providers) Group II participants were not enrolled to the study and participated only in study development. 0 None 0 0 0 0 View
Group III (Medical Oncology Providers) Group III participants were not enrolled to the study and participated only in study development. 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):