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 @ 2:31 PM
Ignite Modification Date: 2025-12-25 @ 1:04 PM
NCT ID: NCT02499159
Description: None
Frequency Threshold: 0
Time Frame: From procedure until the 30-day (plus or minus 10 days) post-procedure phone call.
Study: NCT02499159
Study Brief: Pain Management in Response to Exparel vs. Standard Bupivicaine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Exparel Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. Liposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle. 0 None 1 49 5 49 View
0.25% Standard Bupivicaine Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. 0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle. 0 None 0 49 0 49 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Amaurosis Fugax NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nose bleeds NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Urinary blockage NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Brain tumor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Occipital Neuralgia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View