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 @ 3:55 AM
Ignite Modification Date: 2025-12-26 @ 2:46 AM
NCT ID: NCT01632202
Description: None
Frequency Threshold: 0
Time Frame: Post-operative Day 1, Post-operative Day 7, and Post-operative Day 30
Study: NCT01632202
Study Brief: Seprafilm Slurry in the Prevention of Uterine Scarring in Patients Undergoing Hysteroscopic Myomectomy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Seprafilm Slurry The investigators hypothesize that by placing a slurry of Seprafilm in the intrauterine cavity and creating a temporary physical barrier between the walls of the uterus, that we will be able to prevent iatrogenic intrauterine adhesions. Given that approximately 24 to 48 hours after placement, the membrane becomes a hydrated gel that is slowly resorbed within one week, we anticipate that the patient will have minimal to no discomfort; since no physical device is being left in the endometrial cavity, the uterus will not be contracting more than it does in its normal postoperative state. Seprafilm: Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and carboxymethylcellulose (CMC). Together, these biopolymers have been chemically modified with the activating agent 1-(3-dimethylaminopropyl) -3- ethylcarbodiimide hydrochloride (EDC). 0 None 0 1 1 1 View
Placebo For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline. Sterile Saline Solution: For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline. 0 None 0 7 7 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vaginal Discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Flu SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pelvic Pain SYSTEMATIC_ASSESSMENT General disorders None View
Uterine Cramps SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal Bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View