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 @ 12:19 AM
Ignite Modification Date: 2025-12-25 @ 10:22 PM
NCT ID: NCT01842958
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
Study: NCT01842958
Study Brief: Straumann Roxolid Multi-Center Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
4.1 mm Implant Diameter Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region 0 None 1 25 13 25 View
3.3 mm Implant Diameter Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region 0 None 0 25 7 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Implant hit root of adjacent tooth SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Minimal bone loss around implant SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Implant mobility SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Radiolucency around implant SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Oral ulcer SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain due to bruxism SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Tooth caries SYSTEMATIC_ASSESSMENT General disorders None View
Adjacent tooth fracutre SYSTEMATIC_ASSESSMENT General disorders None View
Vaginal yeast infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Adaptor broke in implant SYSTEMATIC_ASSESSMENT Product Issues None View
Burning sensation on labial mucosa SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Post op paraesthesia lower left labial mucosa SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Prosthetic related complication SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Pain at implant site SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View