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 @ 2:09 AM
Ignite Modification Date: 2025-12-26 @ 12:36 AM
NCT ID: NCT00209560
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT00209560
Study Brief: A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Minor Surgical Procedures
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fospropofol Disodium 525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed. None None 1 121 104 121 View
Midazolam 0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed. None None 0 42 31 42 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendictis None Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dysgeusia None Nervous system disorders None View
Pruritus genital None Reproductive system and breast disorders None View
Anal discomfort None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Pruritus ani None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Chills None General disorders None View
Pain None General disorders None View
Incision site complication None Injury, poisoning and procedural complications None View
Post procedural pain None Injury, poisoning and procedural complications None View
Procedural complication None Injury, poisoning and procedural complications None View
Alanine aminotransfersase increased None Investigations None View
Aspartate aminotransferase increased None Investigations None View
Gamma-glutamyltransferase increased None Investigations None View
Hepatic enzyme increased None General disorders None View
White blood cell count increased None General disorders None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Pain in extremity None Musculoskeletal and connective tissue disorders None View
Burning sensation None Nervous system disorders None View
Dizziness None Nervous system disorders None View
Headache None Nervous system disorders None View
Paraesthesia None Nervous system disorders None View
Genital burning sensation None Reproductive system and breast disorders None View
Paraesthesia of genital female None Reproductive system and breast disorders None View
Hypoxia None Respiratory, thoracic and mediastinal disorders None View
Pruritus None Skin and subcutaneous tissue disorders None View
Pruritus generalized None Skin and subcutaneous tissue disorders None View
Hypotension None Vascular disorders None View