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 @ 11:24 PM
Ignite Modification Date: 2025-12-25 @ 9:09 PM
NCT ID: NCT04075656
Description: During study visits, caregivers were asked if their child had any serious illnesses or trips to the hospital since the last study visit. Information on non-serious adverse events among pediatric patients was not collected. Information about adverse events impacting caregiver participants was not collected.
Frequency Threshold: 0
Time Frame: Information on adverse events among pediatric patients was collected beginning one month after initiating the intervention and Months 6 and 12 (up to 11 months).
Study: NCT04075656
Study Brief: UrApp for Childhood Nephrotic Syndrome Management (Incident Cohort)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
UrApp Pediatric patients of caregiver participants randomized to this study arm use the UrApp mobile application for one year, in addition to receiving the standard of care. 0 None 5 30 0 0 View
Standard of Care Pediatric patients of caregiver participants randomized to this study arm receive the standard of care for one year. 0 None 9 28 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization due to anasarca NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hospitalization due to fever, concern for infection, or immunosuppression NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization due to peritonitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization due to acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hospitalization due to electrolyte derangements NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hospitalization due to high blood sugar NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hospitalization due to gastrointestinal parasite NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):