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 @ 2:11 AM
Ignite Modification Date: 2025-12-26 @ 12:39 AM
NCT ID: NCT01285960
Description: 2 subjects receiving fewer than 10 sonications were added to the sample size of 106 treated subjects for a total safety sample size of 108
Frequency Threshold: 0
Time Frame: 1 month
Study: NCT01285960
Study Brief: ExAblate UF V2 System for the Treatment of Symptomatic 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
ExAblate Treatment UF V2 ExAblate MRgFUS Treatment ExAblate Treatment UF V2: Treatment with the ExAblate UF V2 system. Patients may have up to two ExAblate treatments within a two-week period. 0 None 1 108 102 108 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Bowel Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Increased urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pain or burning at urinary catheter site SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Difficulty initiating urination SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary tract infection (UTI) SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin burn SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Small bruise at IV Site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Edema/Hypo-intense tissu SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Nausea/vomiting SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea/vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Generalized GI upset and decreased activity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomach cramping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bloody mucus in stool SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal cramping SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Dyspareunia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Menstrual cramping SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Back pain during period SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal bleeding between periods SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Leg/calf pain SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness/vertigo SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tingling sensation in spine SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Left leg anterior compartment tenderness SYSTEMATIC_ASSESSMENT General disorders None View
Decreased sensation in right foot SYSTEMATIC_ASSESSMENT General disorders None View
IV infiltration SYSTEMATIC_ASSESSMENT General disorders None View
Position Pain SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Sonication Pain SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Sonication-related epidermal pain SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Sonication related neuromuscular pain SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever/chills SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Post-embolization like symptoms SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View