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 @ 2:17 AM
Ignite Modification Date: 2025-12-26 @ 12:48 AM
NCT ID: NCT02679560
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
Study: NCT02679560
Study Brief: Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Liposomal Bupivacaine In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will be administered Liposomal Bupivacaine: A fascia iliaca compartment block using liposomal bupivacaine will require less total opioid administration compared to a fascia iliaca block using 0.2% ropivacaine 0 None 0 1 0 1 View
Ropivacaine HCL In patients with femur or hip fractures, a fascia iliaca block using using 0.2% ropivacaine will be administered Ropivacaine HCL: Ropivacaine HCL is a member of the amino amide class of local anesthetics. Naropin injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and water for injection. It is administered parenterally. 0 None 0 2 1 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mild edema NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
mild muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
hallucination NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
diaphoresis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
fever NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
elevated systolic blood pressure NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
tachypnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
moderate orthostatic hypotension NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View