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: 2025-12-26 @ 5:20 PM
Ignite Modification Date: 2025-12-26 @ 5:20 PM
NCT ID: NCT00760006
Description: As noted in the protocol exclusion criteria, children already receiving antibiotics at the time of their surgery were evaluated distinctly, though they were not included in the antibiotic or placebo groups. Only participants receiving preoperative antibiotics are considered for outcome measure and adverse events.
Frequency Threshold: 0
Time Frame: None
Study: NCT00760006
Study Brief: Preventing Complications in Cleft Palate Repair With Antibiotics
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Unasyn Antibiotic Arm Unasyn® is a parenteral antibiotic that combines ampicillin with sulbactam, a beta-lactamase inhibitor. All subjects enrolled in the study will receive a single dose of antibiotic or saline solution (placebo control) intravenously, as the IV will already be in place as standard of care for surgery. The study aims to assess the efficacy of the prophylactic antibiotic in cleft surgery to: decrease the incidence of surgical site infections, speed the progression of postoperative healing, improve the final quality of wound healing achieved, and decrease the rate of palatal fistula formation. Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure. Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm 0 None 0 86 0 86 View
Saline Placebo Arm Other Names: * Salt solution * Saline Solution Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure. Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm 0 None 0 138 0 138 View
Serious Events(If Any):
Other Events(If Any):