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 @ 12:16 PM
Ignite Modification Date: 2025-12-25 @ 12:01 PM
NCT ID: NCT00837161
Description: Adverse events assessed by patient questionnaire. Only unexpected adverse events were reported in the "Other" Adverse Event Field. All adverse events were reported including those not related to treatment.
Frequency Threshold: 5
Time Frame: Feb 9, 2009 through March 9, 2010
Study: NCT00837161
Study Brief: Pilot Study of MRI-Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
HIFU Treatment None None None 0 11 6 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Descriptive View
Pain at Rib Cage or Chest Level SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Descriptive View
Right leg pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Descriptive View
Rectal Bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Descriptive View
Fatigue SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders Descriptive View
Shin discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Descriptive View
pain right buttock SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Descriptive View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Descriptive View
Shoulder pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Descriptive View
Right foot swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Descriptive View
Fever SYSTEMATIC_ASSESSMENT General disorders Descriptive View
Cold SYSTEMATIC_ASSESSMENT General disorders Descriptive View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Descriptive View
Lower back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Descriptive View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Descriptive View
Pruritis SYSTEMATIC_ASSESSMENT General disorders Descriptive View
Sharp burning pain at abdomen SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Descriptive View