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 @ 4:42 AM
Ignite Modification Date: 2025-12-26 @ 3:44 AM
NCT ID: NCT00545818
Description: None
Frequency Threshold: 5
Time Frame: 5 years
Study: NCT00545818
Study Brief: Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior 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-1, Implant Length 6 mm Subjects treated with OsseoSpeed™ implant, length: 6 mm None None 8 49 13 49 View
Group-2, Implant Length 11 mm Subjects treated with OsseoSpeed™ implant, length: 11 mm None None 5 46 12 46 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Undefined heart problems SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Failure knee-prosthesis SYSTEMATIC_ASSESSMENT Product Issues None View
Hip function failure SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Gallbladder removed SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Right hip replacement, post-op infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Armpit abscess due to spider bite. SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Arteriosclerosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Bilateral toe infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Liver cancer NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Broken pelvis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ovarian cancer SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Eye cancer (basal cell carcinoma) SYSTEMATIC_ASSESSMENT Eye disorders None View
Squamous cell skin cancer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Osteopaenia, trauma - fractured toes NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Insufficient renal function (30%) SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pneumonitis - Non Hodgkin disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hip fracture due to car accident SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bridge screw loosening NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Study implant failure NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Abutment fracture NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Fracture of temporary bridge SYSTEMATIC_ASSESSMENT Product Issues None View