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 @ 3:03 AM
Ignite Modification Date: 2025-12-26 @ 1:43 AM
NCT ID: NCT01760733
Description: The term serious adverse event describes number of patients who are removed from the transplantation waiting list because of medical reasons and patients with graft loss after transplantation. All cause mortality is reported from both patients on the waiting list and those who have received a transplant.
Frequency Threshold: 5
Time Frame: This is an observational study describing HRQoL among elderly Kidney Transplant candidates, longitudinally before and after KTx. No experimental interventions are performed and consequently adverse advents other than death, graft loss and being removed from the waiting list are not collected. Data are reported continuously from the clinicians to the Norwegian Renal Registry and exported to the study database. We search the registry every month and update our study database accordingly.
Study: NCT01760733
Study Brief: Improved Selection of Elderly (> 65 Years) for Kidney Transplantation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Question 65 Patients on the waiting list for transplantation - 5 years post KTx Observational study 44 None 48 289 0 289 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Removed from the transplantation wait-list SYSTEMATIC_ASSESSMENT General disorders None View
Graft loss SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):