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: 2025-12-25 @ 3:33 AM
Ignite Modification Date: 2025-12-26 @ 2:15 AM
NCT ID: NCT05463705
Description: Because this was a low-risk study conducted within routine primary care, adverse events were monitored passively through information reported to the study team by physician participants as well as through general monitoring of the safety reporting system used within the practices that is reviewed by the study site lead. This monitoring plan was approved by the study's DSMB and reporting was conducted throughout the study.
Frequency Threshold: 0
Time Frame: Adverse events were passively collected for patients. Adverse event monitoring began the day each patient entered the study and continued through the 6-month follow-up period. Additionally, any adverse events that were noted during chart review data collection through the primary completion date were captured and reported.
Study: NCT05463705
Study Brief: Addressing Diffusion of Responsibility and Prescribing Burden to Improve Use of Diabetes Medications
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Usual Care - Patients Patients were not intervened upon directly. PCPs in this arm received no additional outreach or resources. 3 None 0 459 0 459 View
Intervention to Address Diffusion of Responsibility - Patients Patients were not intervened upon directly. In this arm, PCPs received support for SGLT2i and GLP-1RA prescribing from the peer champions including a welcome email offering encouragement and support in prescribing, electronic health record (EHR) messages containing prescribing tips sent before visits with eligible patients, and a hand-signed note with a prescribing tips sheet from the peer champion. 1 None 0 484 0 484 View
Intervention to Address Diffusion of Responsibility + Simplification of Prescribing - Patients Patients were not intervened upon directly. In this arm, PCPs received support for SGLT2i and GLP-1RA prescribing from the peer champions including a welcome email offering encouragement and support in prescribing and a hand-signed note with a prescribing tips sheet from the peer champion. In this arm, electronic health record (EHR) messages sent before visits with eligible patients contained information on insurance coverage for SGLT2i and GLP-1RA medications specific to each patient. 2 None 0 446 0 446 View
Usual Care - Providers PCPs in this arm received no additional outreach or resources. 0 None 0 62 0 62 View
Intervention to Address Diffusion of Responsibility - Providers In this arm, PCPs received support for SGLT2i and GLP-1RA prescribing from the peer champions including a welcome email offering encouragement and support in prescribing, electronic health record (EHR) messages containing prescribing tips sent before visits with eligible patients, and a hand-signed note with a prescribing tips sheet from the peer champion. 0 None 0 66 0 66 View
Intervention to Address Diffusion of Responsibility + Simplification of Prescribing - Providers In this arm, PCPs received support for SGLT2i and GLP-1RA prescribing from the peer champions including a welcome email offering encouragement and support in prescribing and a hand-signed note with a prescribing tips sheet from the peer champion. In this arm, electronic health record (EHR) messages sent before visits with eligible patients contained information on insurance coverage for SGLT2i and GLP-1RA medications specific to each patient. 0 None 0 63 0 63 View
Serious Events(If Any):
Other Events(If Any):