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 @ 4:45 PM
Ignite Modification Date: 2025-12-25 @ 2:32 PM
NCT ID: NCT02604550
Description: Any change from baseline considered by the investigator to be an untoward medical occurrence different from the standard of care, was reported as an adverse event. Any change from baseline considered by the investigator to be part of the normal daily fluctuations of the underlying disease process, was not reported as an adverse event.
Frequency Threshold: 0
Time Frame: Data regarding adverse events were collected from the time a participant gave informed consent to take part in the study until the end of the study follow up.
Study: NCT02604550
Study Brief: Anterior Cruciate Ligament Pain Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Femoral Nerve Block Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve. 0 None 0 56 0 56 View
Adductor Canal Block Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal 0 None 0 59 0 59 View
Serious Events(If Any):
Other Events(If Any):