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 @ 9:22 PM
Ignite Modification Date: 2025-12-25 @ 7:09 PM
NCT ID: NCT01393704
Description: If an adverse event occurs to any patients enrolled in this study, the primary investigator will conduct an investigation to determine if the event was related to the study protocol (ie: administration of vasopressin). If the event is clearly linked, or insufficient data exists to determine relationship of event to study protocol, then the investigator will report the event to the IRB. Any protocol-related complication will be communicated to investigators at other sites as well.
Frequency Threshold: 0
Time Frame: Adverse events data was collected for a period of 4 years, from the start of the study (July 2011), to completion of the study (June 2015). The time frame for reporting adverse events will be within 7 calendar days of the adverse event. Patients were assessed from the time of their initial consult to 8 weeks following surgery.
Study: NCT01393704
Study Brief: Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
High Volume Dilute Vasopressin 20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used). Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy. None None 0 76 0 76 View
Low Volume Dilute Vasopressin 20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used). Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy. None None 0 76 0 76 View
Serious Events(If Any):
Other Events(If Any):