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 @ 6:47 PM
Ignite Modification Date: 2025-12-25 @ 4:19 PM
NCT ID: NCT00318357
Description: No Serious Adverse Events or Adverse events were collected during the CARE-HF LTFU study. All-Cause Mortality was monitored/assessed. Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
Frequency Threshold: 0
Time Frame: 8-year. The patients that were still alive after closure of the CARE-HF study (2005,NCT00170300), that were willing to participate in the CARE-HF LTFU study continued additional follow-up for 4 years, till end 2009. The reported mortality data is the combined mortality of the CARE-HF and the CARE-HF LTFU study. Study start CARE-HF 2000.During the CARE-HFF LTFU study only mortality data was collected, no other adverse event data was collected..
Study: NCT00318357
Study Brief: CARE-HF Long Term Follow-up
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cardiac REsynchronization Therapy None 39 None 0 0 0 0 View
Upgrade to Cardiac Resynchronization Therapy CARE-HF LTFU study continued to follow up the original CARE-HF control group patients. With a recommended implantation of a Medtronic CRT InSync® family devices. Implantation of CRT device and medical treatment according normal hospital routine. 32 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):