Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 10:32 PM
Ignite Modification Date: 2025-12-25 @ 8:04 PM
NCT ID: NCT00820235
Description: None
Frequency Threshold: 5
Time Frame: 5 years
Study: NCT00820235
Study Brief: Study Comparing Appearance and Function of Three Different Dental Implant Designs When Placed in Front Region of Upper Jaw
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group-A. OsseoSpeed™ Implant Subjects that had OsseoSpeed™ implants installed. None None 8 48 8 48 View
Group-B. NobelSpeedy™ Replace® Implant Subjects that had NobelSpeedy™ Replace® implants installed None None 3 49 23 49 View
Group-C. NanoTite™ Certain® PREVAIL® Implant Subjects that had NanoTite™ Certain® PREVAIL® implants installed None None 8 44 10 44 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Breast cancer SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Hospitalized due to fever after mastectomy SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalized for partial nephrectomy SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hospitalised for gall bladder surgery SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hospitalized for follow-up on chest pains SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalized for spine fusion surgery SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hospitalized for gastric surgery SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hospitalized for surgery of infected appendix SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hospitalized for knee replacement SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hospitalization after heart attack SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Death caused by heart attack SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalized due to episode of bi-polar disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hospitalized for fractured leg after an accident SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hospitalized due to pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hospitalization due to hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Colon cancer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hospitalized for treatment of infection after vaccination SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalized due to menstrual hemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Study implant failled to osseointegrate SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Study implant temporary mobile SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Restoration failure SYSTEMATIC_ASSESSMENT Product Issues None View
Loose abutments SYSTEMATIC_ASSESSMENT Product Issues None View
Other SYSTEMATIC_ASSESSMENT General disorders None View