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 @ 6:35 PM
Ignite Modification Date: 2025-12-25 @ 4:05 PM
NCT ID: NCT01825057
Description: The Adverse Event Table combines within each arm the number of patient participants and the number of provider participants at risk. Hence, See One includes 336 patient participants and 13 provider participants (subtotal = 349); Do One includes 379 patient participants and 12 provider participants (subtotal = 391); and Order One includes 458 patient participants and 13 provider participants (subtotal = 471). In total, we document adverse events for 1211 participants at risk.
Frequency Threshold: 0
Time Frame: For provider participants, adverse events were monitored/collected over the course of their implementation trial participation from study enrollment until they were assigned their last patient participant; across provider participants, this period was up to one year. For patient participants, adverse events were monitored/collected from study enrollment through the period in which the provider participants were assigned to their care; across patient participants, this period was up to one week.
Study: NCT01825057
Study Brief: Three Strategies for Implementing Motivational Interviewing on Medical Inpatient Units
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
See One Providers in See One only receive MI workshop training, giving them an opportunity to "see" the MI intervention and learn how to conduct it. The trainer encourages them to screen their patients for substance misuse and apply MI as indicated. 0 None 0 349 0 349 View
Do One Following workshop training, MI-trained CL clinicians directly supervise providers' live bedside provision of MI to patients twice before beginning the trial and once midstream. In addition, providers have the option to request additional live supervision from CL clinicians during the trial, consistent with the apprenticeship model. 0 None 0 391 0 391 View
Order One Following the workshop, providers either administer MI themselves or "order" a MI for delivery by one of the MI-trained CL clinicians. Only providers in Order One can specifically request MI through a separate CL order in the electronic health record. The physicians or PAs directly place MI orders. Nurses contact physicians or PAs to place the MI order. The CL clinicians are trained in MI via a clinical trials training approach: 1) a 2-day skill-building workshop; 2) three post-workshop supervised practice cases based on review of audio recorded sessions; and 3) follow-up monthly group supervision to maintain and monitor the CL clinicians' MI practice. CL clinicians also learned supervisory practices to provide live supervision to providers in Do One. 0 None 0 471 0 471 View
Serious Events(If Any):
Other Events(If Any):