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 @ 7:56 PM
Ignite Modification Date: 2025-12-25 @ 5:31 PM
NCT ID: NCT01827904
Description: For the Exablate and Crossover Groups Adverse Events were assessed at each follow-up study visit through the 5 Year post treatment follow-up. For the Sham Group Adverse were assessed and reported through the 3 Months post treatment follow-up.
Frequency Threshold: 0
Time Frame: Intraoperative through 5 Years. Adverse events were assessed at 3 months, 6 months, 12 months and annually for years 2 through 5.
Study: NCT01827904
Study Brief: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Crossover Transcranial Exablate After completing the 3 Month visit subjects randomized to the Sham group were presented with the opportunity to receive the Exablate treatment and continue in the study in the Crossover group. Nineteen subjects opted to continue in the Crossover group. Two subjects randomized to the Exablate test group received suboptimal treatment, were retreated, and followed in the Crossover group. Thus the total number of subjects in the initially in the Crossover group was 21. 0 None 0 21 19 21 View
Transcranial ExAblate Transcranial ExAblate Transcranial ExAblate 0 None 6 56 49 56 View
Sham Transcranial ExAblate Sham Treatment with Transcranial ExAblate Sham Transcranial ExAblate 0 None 0 20 6 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Embolic Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Numbness and Tingling SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders Custom View
Syncopal episode SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders Custom View
Breast cancer SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders Custom View
TIA SYSTEMATIC_ASSESSMENT Vascular disorders Custom View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders Custom View
Hypertentsion SYSTEMATIC_ASSESSMENT Vascular disorders Custom View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders Custom View
TIA SYSTEMATIC_ASSESSMENT Vascular disorders Custom View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders Custom View
Preventricular contractions SYSTEMATIC_ASSESSMENT Cardiac disorders Custom View
Sick sinus syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders Custom View
Vision problems SYSTEMATIC_ASSESSMENT Eye disorders Custom View
Watering eyes SYSTEMATIC_ASSESSMENT Eye disorders Custom View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Custom View
Dysergia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Custom View
Dysmetria SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Custom View
Gait disturbance SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Custom View
Imbalance SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Custom View
Musculoskeletal weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Custom View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Custom View
Positional pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Custom View
Unsteady SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Custom View
Anxiety SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Cognitive disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Dysesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Dysgnosia SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Dysmetria SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Dysmnesia SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Grogginess SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Sonication-related head pain SYSTEMATIC_ASSESSMENT General disorders Custom View
Ptosis SYSTEMATIC_ASSESSMENT Product Issues Custom View
Facial edema SYSTEMATIC_ASSESSMENT Product Issues Custom View
Numbness / Tingling SYSTEMATIC_ASSESSMENT Product Issues Custom View
Pin site bleeding SYSTEMATIC_ASSESSMENT Product Issues Custom View
Pin site edema SYSTEMATIC_ASSESSMENT Product Issues Custom View
Pin site pain SYSTEMATIC_ASSESSMENT Product Issues Custom View
Pin site abrasion SYSTEMATIC_ASSESSMENT Product Issues Custom View
Bruising SYSTEMATIC_ASSESSMENT Product Issues Custom View
Catheter irritation SYSTEMATIC_ASSESSMENT Renal and urinary disorders Custom View
Urinary urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders Custom View
BPH SYSTEMATIC_ASSESSMENT Renal and urinary disorders Custom View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders Custom View
Dizziness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders Custom View
Paroxysmal vertigo issues SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders Custom View
Hiccups SYSTEMATIC_ASSESSMENT General disorders Custom View
Skin rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Custom View
Flu SYSTEMATIC_ASSESSMENT Infections and infestations Custom View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations Custom View
Numbness/Tingling SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Slow movements SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Slurred speech SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Ankle pain SYSTEMATIC_ASSESSMENT General disorders Custom View
Foot pain SYSTEMATIC_ASSESSMENT General disorders Custom View
Headache SYSTEMATIC_ASSESSMENT General disorders Custom View
Restlessness SYSTEMATIC_ASSESSMENT General disorders Custom View
Common cold SYSTEMATIC_ASSESSMENT Infections and infestations Custom View
Dysgeusia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Custom View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Custom View
Nausea/Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Custom View
Increased salivation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Custom View
Fatigue SYSTEMATIC_ASSESSMENT General disorders Custom View
Weakness SYSTEMATIC_ASSESSMENT General disorders Custom View
Impatience SYSTEMATIC_ASSESSMENT General disorders Custom View
Hand tremor (untreated side) SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Involuntary movements-UE SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View
Memory deterioration SYSTEMATIC_ASSESSMENT Nervous system disorders Custom View