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 @ 7:48 PM
Ignite Modification Date: 2025-12-25 @ 5:25 PM
NCT ID: NCT01195103
Description: No adverse event data were collected for the patient who withdrew prior to receiving study drug, so that patient was not included in the assessment of adverse events.
Frequency Threshold: 0
Time Frame: Patients were followed for adverse events from the time of drug administration until entry into the operating room. Patients were sedated again for the surgery. We only studied the first sedation.
Study: NCT01195103
Study Brief: Lusedra (Fospropofol Disodium) for Minimal to Moderate Sedation for Regional Anesthesia Block Prior to Orthopedic Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
10 mg/kg Lusedra 10 mg/kg Lusedra initial bolus None None 1 5 5 5 View
6.5 mg/kg Lusedra 6.5 mg/kg Lusedra initial bolus None None 0 2 1 2 View
Placebo + Midazolam Placebo initial bolus with dose of midazolam based on patient's weight None None 0 5 2 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
deep sedation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
delayed recovery from sedation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
puritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View