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 @ 12:44 AM
Ignite Modification Date: 2025-12-25 @ 10:56 PM
NCT ID: NCT01628367
Description: None
Frequency Threshold: 3
Time Frame: 2 years
Study: NCT01628367
Study Brief: Guided Bone Regeneration Around Immediate Implants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Test Membrane: Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket. Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area. None None 0 16 1 16 View
Control Collagen plug: Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket. Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket None None 0 16 0 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Implant Failure NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View