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 @ 11:40 PM
Ignite Modification Date: 2025-12-25 @ 9:31 PM
NCT ID: NCT02700451
Description: None
Frequency Threshold: 0
Time Frame: 2-year
Study: NCT02700451
Study Brief: Post-op Acetaminophen vs NSAID Use on Lumbar Spinal Fusion Outcomes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
IV Ketorolac IV Ketorolac arm Ketorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. Age 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. 0 None 10 44 40 44 View
Intravenous (IV) Placebo IV Placebo arm Placebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. 0 None 9 43 40 43 View
IV Acetaminophen IV Acetaminophen arm Acetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. 0 None 11 41 38 41 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Operative SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Radiographic SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Renal SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vascular SYSTEMATIC_ASSESSMENT Vascular disorders None View
Wound SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other SYSTEMATIC_ASSESSMENT General disorders None View
Cardiopulmonary SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
cardiovascular SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Fall (mechanical) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall (syncope) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Implant-related SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neurologic SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
fall (mechanical) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
fall (syncope) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
implant-related SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
neurologic SYSTEMATIC_ASSESSMENT Nervous system disorders None View
operative SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
radiographic SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
renal SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
vascular SYSTEMATIC_ASSESSMENT Vascular disorders None View
wound SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
other SYSTEMATIC_ASSESSMENT General disorders None View
cardiopulmonary SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
cardiovascular SYSTEMATIC_ASSESSMENT Endocrine disorders None View