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 @ 10:58 PM
Ignite Modification Date: 2025-12-25 @ 8:27 PM
NCT ID: NCT03472469
Description: None
Frequency Threshold: 0
Time Frame: From hospital admission to hospital discharge (about 30 days)
Study: NCT03472469
Study Brief: MAST Trial: Multi-modal Analgesic Strategies in Trauma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Original MMPR - Descending Dose Arm Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously (IV)/per oral (PO) q6 hours in the first 48 hours, and Acetaminophen 1g PO q6 hours thereafter; 2. Ketorolac 30mg IV once and Celebrex 200mg PO q12 hours in the first 48 hours, and Naproxen 500mg PO q12 hours thereafter; 3. Tramadol 100mg PO q6 hours in the first 48 hours, and Tramadol 100mg PO q6 hours thereafter; 4. Pregabalin 100mg PO q8 hours in the first 48 hours, and Gabapentin 300mg PO q8 hours thereafter; 5. Lidocaine patch q12 hours in the first 48 hours, and Lidocaine patch q12 hours thereafter; and 6. Opioids (Regional anesthesia) in the first 48 hours, and Opioids and Regional anesthesia thereafter. 29 None 29 787 0 787 View
MAST MMPR - Escalating Dose Arm Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g PO q6 hours at admission and thereafter; 2. Ketorolac 30mg IV once and Naproxen 500mg PO q12 hours at admission and thereafter; 3. No drug; 4; Gabapentin 300mg PO q8 hours at admission and thereafter; 5. Lidocaine patch q12 hours at admission and thereafter; and 6. Tramadol and Opioids and Regional anesthesia at admission and thereafter. 36 None 36 774 0 774 View
Serious Events(If Any):

Serious Events

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