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 @ 2:01 AM
Ignite Modification Date: 2025-12-26 @ 12:25 AM
NCT ID: NCT04603560
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 for 9 months.
Study: NCT04603560
Study Brief: Personalizing Intervention to Reduce Clinical Inertia in the Treatment of Hypertension
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Social Norming In this arm, rates of blood pressure control across all patients with hypertension cared for by each PCP were obtained from a system-wide performance dashboard, and reports were generated that displayed the physician's hypertension control rates compared to their peers. To ensure PCPs were compared to targets that they could reasonably attain, a different comparison was used based on the PCP's current rate of hypertension control. If the PCP's rates were below the practice average, the practice average was used for comparison. If the PCP's rate was above the practice average, the rate of the top performer in the practice was used. Adverse events were collected for patients only. 0 None 0 173 0 173 View
Pharmacist E-Detailing In this arm, PCPs received individual feedback and recommendations generated by a clinical pharmacist delivered as a message through the EHR. Eligible patients with an upcoming (target) visit with their PCP were identified using EHR data, as above. A clinical pharmacist reviewed each patient's chart and generated a personalized recommendation for how to modify the specific patient's antihypertensive regimen based on clinical practice guidelines. Adverse events were collected for patients only. 0 None 0 143 0 143 View
Control No intervention will be provided to physicians in the control arm. Adverse events were collected for patients only. 0 None 0 150 0 150 View
Serious Events(If Any):
Other Events(If Any):