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 @ 7:13 PM
Ignite Modification Date: 2025-12-25 @ 4:49 PM
NCT ID: NCT02777203
Description: Patient were followed continuously for six weeks post-operatively.
Frequency Threshold: 0
Time Frame: 6 weeks
Study: NCT02777203
Study Brief: Power Morcellation Systems for Laparoscopic Hysterectomy and 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
Patients Utilizing ecosacT400 Bag Patients undergoing hysterectomy and myomectomy utilizing morcellation and the EcosacT400 bag 0 None 0 60 25 60 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
post op urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
umbillical drainage SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Incisional pain SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
chest pain SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
leg numbness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Broken instrument SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
bruising around incision sites SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
post operative nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Peritoneal rent SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vaginal discharge/yeast infection SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View