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 @ 3:43 PM
Ignite Modification Date: 2025-12-25 @ 1:52 PM
NCT ID: NCT01411592
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01411592
Study Brief: Single Retainer All-Ceramic Resin-bonded Fixed Dental Protheses
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Panavia 21 TC 16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer. Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer. Patients were recalled after 6 and 12 months, and then annually. None None 0 16 1 16 View
Multilink 14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system \[A/B primer and Multilink-Automix\] with Metal/Zirconia primer). Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer). Patients were recalled after 6 and 12 months, and then annually. None None 0 14 1 14 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Debonding NON_SYSTEMATIC_ASSESSMENT Investigations None View
[Small Caries lesion] NON_SYSTEMATIC_ASSESSMENT Investigations None View
[Rotation of abutment tooth] NON_SYSTEMATIC_ASSESSMENT Investigations None View