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: 2025-12-26 @ 10:46 PM
Ignite Modification Date: 2025-12-26 @ 10:46 PM
NCT ID: NCT02155712
Description: All operative site events occurring at any time, as well as all serious adverse events (SAEs) occurring in the perioperative period (intraoperative to hospital discharge), are collected. Specific Adverse Event terms are not used for all Adverse Events.
Frequency Threshold: 5
Time Frame: Adverse event data is provided from enrollment through the 8-year postoperative interval for the cementless Cohort 1 with a mean of 4.4 years. For the cemented Cohort 2, the period was from enrollment to the 5.6 years postoperative interval with a mean of 3.1 years.
Study: NCT02155712
Study Brief: Triathlon Tritanium Knee Outcomes 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
Cohort 1 Cementless Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application. Triathlon Tritanium Knee: Cementless 12 None 28 319 69 319 View
Cohort 2 Cemented Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application. Triathlon Knee: Cemented 0 None 8 134 12 134 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Non-operative NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Non-operative NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Operative site NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Operative site NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Operative site NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Non-operative NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Non-operative NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Operative site NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Operative site NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Operative site NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View