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: 2025-12-24 @ 6:48 PM
Ignite Modification Date: 2025-12-25 @ 4:20 PM
NCT ID: NCT03062657
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data were collected from baseline to participant completion; specifically the pre-operative, 6 weeks, 3-months, 6-months and 12-months follow-up visits.
Study: NCT03062657
Study Brief: An Investigation of the Metal Concentration in Patients Implanted With the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels in the Cervical Spine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PRESTIGE LP Patients receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7. PRESTIGE LP™ Cervical Disc: The PRESTIGE LP™ Cervical Disc is an artificial cervical disc comprising of two low-profile metal plates that interface through a ball and trough mechanism, permitting segmental spinal motion. The PRESTIGE LP™ Cervical Disc was approved by the Food and Drug Administration (FDA) to be used at a single and two contiguous levels. 0 None 4 25 14 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arm Pain (Non-Cervical) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Spinal Cord Disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Pain SYSTEMATIC_ASSESSMENT General disorders None View
Spinal Event (Cervical Non-Study Surgery) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dysphagia/Dysphonia (Grade 1/2) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neck and/or Arm Pain (Grade 1/2) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neurological (Grade 1/2) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Pain (Grade 1/2) SYSTEMATIC_ASSESSMENT General disorders None View
Trauma (Grade 1/2) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View