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 @ 1:29 PM
Ignite Modification Date: 2025-12-25 @ 12:32 PM
NCT ID: NCT03832595
Description: None
Frequency Threshold: 5
Time Frame: Over the entire study follow-up period, median follow-up 17 months
Study: NCT03832595
Study Brief: Kidney Coordinated Health Management Partnership
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention Arm Patients will receive a care bundle EHR-based PHM: An EHR in-basket message will be sent to the patient's PCP which identifies the patient's high-risk CKD status and indicates that the patient will receive: 1. Nephrologist led electronic consultation: review of the patient's EHR with recommendations sent to the PCP every \~6 months, 2. Medication therapy management: PharmD led telephonic medication therapy management with the patient every \~6 months, 3. and Nurse led CKD patient education, every \~6-12 months unless the PCP opts the patient out of the interventions (by responding to the EHR in-basket message and providing an opt-out reason or requesting an office consultation with nephrology). 142 None 18 754 59 754 View
Usual Care Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice). Usual Care: Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice). 130 None 21 842 77 842 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Severe Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Moderate hyperkalemia (Serum potassium 5.5 - 6 meQ/L) NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View