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 @ 9:16 PM
Ignite Modification Date: 2025-12-25 @ 7:05 PM
NCT ID: NCT01714804
Description: Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
Frequency Threshold: 0
Time Frame: Up to 24 months post surgery
Study: NCT01714804
Study Brief: Efficacy and Safety of Integra Accell Evo3 DBM in Instrumented Lumbar Spine Fusion
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Infuse Retrospective patients who were treated with posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Infuse (rh-BMP2) was used with autogenous cancellous bone in the posterolateral space. 0 None 2 30 6 30 View
Accell Evo3 Prospectively enrolled patients who required posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Accell Evo3 was used with autogenous cancellous bone in the posterolateral space. 0 None 7 29 6 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hematoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Adjacent segment disease SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blood Pressure increase SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cataract surgery SYSTEMATIC_ASSESSMENT Eye disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
carpal tunnel trigger finger SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
CMC arthroplasty, thumb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
epidural hematoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
headache, rib and back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Upper extremity numbness; guyon's canal release SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Surgery for lipoma, right flank SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Back and thigh pain (stinging) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Numbness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fever and burning around incision SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Adjacent segment disease SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dysuria/stress incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Neck and low back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Low back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Flare up of hip pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Buttox pain SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View