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 @ 1:16 PM
Ignite Modification Date: 2025-12-25 @ 12:24 PM
NCT ID: NCT02912195
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02912195
Study Brief: Intravenous Lidocaine Versus Morphine for Severe Pain in the ED
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intravenous Lidocaine Participants will receive IV lidocaine (75 mg if \<50kg, 100 mg if 50 - 100 kg, and 150 mg if \>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \<50kg, 100 mg if 50 - 100 kg, and 150 mg if \>100 kg) in a 100 mL normal saline minibag. At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic. Intravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes None None 0 16 2 16 View
Morphine ED provider will choose an appropriate dose of intravenous morphine for the patient. At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic. Intravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine None None 0 16 6 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Perioral numbness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View