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 @ 4:04 PM
Ignite Modification Date: 2025-12-25 @ 2:05 PM
NCT ID: NCT05221866
Description: 1. All-Cause Mortality: all anticipated and unanticipated deaths due to any cause. 2. Serious Adverse Events: all anticipated and unanticipated serious adverse events, including only inpatient hospitalization 3. Other (Not Including Serious) Adverse Events: A table of anticipated and unanticipated events
Frequency Threshold: 0
Time Frame: Adverse event data was collected from Discharge to Day 28.
Study: NCT05221866
Study Brief: Efficiency And Quality In Post-Surgical Pain Therapy After Discharge
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
UControl Pain App Educational App UControl Pain App with education components. No provider-facing tool. 0 None 11 148 2 148 View
UControlPain App With Only Data Collection Control UControl Pain App with data collection only. No provider-facing tool. 1 None 12 152 1 152 View
UControlPain App With Only Data Collection and Provider Facing Tool UControlPain App with only data collection function and Provider-facing prescription intervention. Participants who were randomized to the control arm (UControlPain App with only data collection), once half the subjects were enrolled (February 13, 2023). 0 None 11 151 0 151 View
UControlPain App and Provider Facing Tool UControlPain app with education components and provider-facing prescription intervention. Participants who were randomized to the intervention arm (UControlPain App) once half the subjects were enrolled (February 13, 2023). 0 None 8 155 0 155 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Re-hospitalization (any reason) SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Requiring greater than 2 additional opioid prescriptions within 2 weeks of discharge SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View