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 @ 7:35 PM
Ignite Modification Date: 2025-12-25 @ 5:16 PM
NCT ID: NCT02190903
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02190903
Study Brief: A Trial To Assess Risk of Delirium in Older Adults Undergoing Hip Fracture Surgery With Spinal or General Anesthesia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
General Endotracheal Anesthesia Standard care general endotracheal anesthesia General endotracheal anesthesia: General Anesthesia Patients randomized to receive general anesthesia induction of anesthesia with intravenous lidocaine, propofol, fentanyl citrate and vecuronium or cisatracurium, following dosing guidelines defined by protocol. Following tracheal intubation, anesthesia will be maintained with sevoflurane in oxygen and air as defined by protocol. End-tidal gas monitoring (for carbon dioxide and sevoflurane) and maintenance, monitoring, and reversal of neuromuscular blockade will be as per HUP and PPMC routine. Immediate postoperative analgesia will be via IV dilaudid dosed intraoperatively as defined by protocol. 0 None 1 6 0 6 View
Regional (Spinal) Anesthesia Standard care spinal anesthesia Regional (spinal) Anesthesia: Patients randomized to receive spinal anesthesia will undergo spinal blockade using standard techniques and medications dosed as per protocol, and will include hyperbaric bupivicaine or tetracaine, fentanyl citrate, and epinephrine; algorithms for management of spinal-related hypotension will be defined by protocol. Intraoperative sedation will be achieved via continuous intravenous propofol infusion; supplemental oxygen will be provided by nasal cannula or facemask as needed. Propofol dose will be titrated to achieve light to moderate sedation, defined as a Richmond Agitation/Sedation Scale (RASS) score of -1 to -318. In the event of block failure induction and maintenance of general endotracheal anesthesia will occur via the procedures outlined above. For all patients, post-operative pain management will be via hydromorphone PCA or PRN hydromorphone bolus, followed by oral oxycodone and acetaminophen. 0 None 0 6 0 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):