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 @ 1:06 AM
Ignite Modification Date: 2025-12-25 @ 11:18 PM
NCT ID: NCT01701193
Description: Safety was assessed though the incidence of adverse drug events (AE) and clinical lab abnormalities. The laparotomy arms were included for safety analysis, and laboratory assessments were conducted at the time of myomectomy and at SLL for all patients that enrolled and completed the study.
Frequency Threshold: 5
Time Frame: Adverse events were monitored for 8 weeks post-myomectomy.
Study: NCT01701193
Study Brief: A Clinical Study of Alanyl-Glutamine for Reduction of Post-Myomectomy Adhesions
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
L-Alanyl/L-Glutamine- Laparoscopic Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of laparoscopic myomectomy. L-Alanyl/L-Glutamine: Sterile solution of L-Alanyl-L-Glutamine, 400mg/mL in water for injection. It is dosed at 1g/kg of body weight and is instilled into the peritoneum at the time of surgery. The active ingredient, glutamine, is a conditionally essential amino acid component of nutritional supplements. 0 None 0 18 3 18 View
Physiological Saline- Laparoscopic Participants receiving intraperitoneal administration of physiological saline at the time of laparoscopic myomectomy. Physiologic saline: Placebo 0 None 0 19 6 19 View
L-Alanyl/L-Glutamine- Laparotomy Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of myomectomy (laparotomy). L-Alanyl/L-Glutamine: Sterile solution of L-Alanyl-L-Glutamine, 400mg/mL in water for injection. It is dosed at 1g/kg of body weight and is instilled into the peritoneum at the time of surgery. The active ingredient, glutamine, is a conditionally essential amino acid component of nutritional supplements. 0 None 0 5 1 5 View
Physiological Saline -Laparotomy Participants receiving intraperitoneal administration of physiological saline at the time of myomectomy (laparotomy). Physiologic saline: Placebo 0 None 0 5 1 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Elevated temperature SYSTEMATIC_ASSESSMENT Infections and infestations None View
Elevated CPK levels SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Elevated AST levels SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View