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: 2025-12-25 @ 12:56 AM
Ignite Modification Date: 2025-12-25 @ 11:10 PM
NCT ID: NCT03133767
Description: Participants responding to the 24-hour phone call and/or the seven-day text could be assessed for adverse events. Therefore, the total of participants in the LR group is 42 (one participant did not respond to the primary outcome, but did respond to the seven-day text to assess secondary outcomes).
Frequency Threshold: 0
Time Frame: Participants could be assessed for adverse events at the phone call 24-48 hours following study enrollment and/or at the text message seven days following study enrollment.
Study: NCT03133767
Study Brief: Saline vs. Lactated Ringers for Emergency Department IV Fluid Resuscitation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lactated Ringers Solution Participants in this arm will receive two liters of IV Lactated Ringer's solution during their emergency department stay Lactated Ringer Solution: 2 liters of intravenous lactated ringers solution will be administered by peripheral IV 0 None 0 42 0 42 View
Normal Saline Solution Participants in this arm will receive two liters of IV 0.9% sodium chloride solution during their emergency department stay Normal Saline 0.9% Infusion Solution Bag: 2 liters of intravenous normal saline solution will be administered by peripheral IV 0 None 0 53 0 53 View
Serious Events(If Any):
Other Events(If Any):