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 @ 11:03 PM
Ignite Modification Date: 2025-12-25 @ 8:34 PM
NCT ID: NCT03560869
Description: There were no adverse events, thus, there are no adverse event outcomes reported.
Frequency Threshold: 0
Time Frame: Adverse event data were monitored throughout the study (during experimental protocol #1 (3 days), study visit #1 (1 day), washout (up to 60 days), experimental protocol #2 (3 days), study visit #2 (1 day), and the week (7 days) following this final study visit - i.e., up to 75 days).
Study: NCT03560869
Study Brief: The Effect of Acute Mild Dehydration on Blood Pressure Control
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Normal Hydration Participants will consume water to maintain proper hydration for three days prior to testing. Hydration State: Hydration State 0 None 0 35 0 35 View
Dehydration Participants will reduce water intake over three days and abstain from any water for the final 16 hours prior to testing. Hydration State: Hydration State 0 None 0 35 0 35 View
Serious Events(If Any):
Other Events(If Any):