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: 2025-12-26 @ 10:18 PM
Ignite Modification Date: 2025-12-26 @ 10:18 PM
NCT ID: NCT01660412
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were monitored for each injection up to 5 minutes.
Study: NCT01660412
Study Brief: Does Alkalinization Reduce Perceived Pain Levels During Sentinel Lymph Node Imaging?
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard of Care Injection Approximately 1mc 99mTc-SC 0 None 0 60 11 60 View
PH Altered Injection a diluted bicarbonate solution in a drop wise manner to raise the pH of the 99mTc-SC to a pH of 7.40 ± 0.05, dose Approximately 1mc 0 None 0 60 0 60 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders None View