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 @ 4:29 AM
Ignite Modification Date: 2025-12-26 @ 3:32 AM
NCT ID: NCT01161420
Description: None
Frequency Threshold: 0
Time Frame: For the submission adverse events were collected from 10 November 2010 to data cut-off of 12 February 2012. Adverse events continue to be collected for long-term follow-up.
Study: NCT01161420
Study Brief: Stimulation Therapy for Apnea Reduction (Www.theSTARtrial.Com)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Inspire Therapy This pivotal trial was to evaluate safety via a description of all reported adverse events. Per the IDE-approved protocol, no formal statistical hypothesis was tested as part of the safety assessment. None None 13 126 107 126 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest Pressure and/or Pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary Artery Disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Rotator Cuff Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Acute Entercolitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Motor Vehicle Accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hernia NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Device Revision - resuture to secure IPG NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Atrial Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Death NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Recurring Syncope NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Knee Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Heart Catheter Procedure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Entercolitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dilated cardiomyopathy NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Drowsiness after Zolpidem administration NON_SYSTEMATIC_ASSESSMENT General disorders None View
Drug reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Dry throat NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dysphagia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ear pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Elevated triglycerides & blood sugar NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Enlarged lymphnodes NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Fatigue related to B12 deficiency NON_SYSTEMATIC_ASSESSMENT General disorders None View
Patient fall NON_SYSTEMATIC_ASSESSMENT General disorders None View
Flu NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Grastic pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal discomfort with nausea and mild diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General malaise NON_SYSTEMATIC_ASSESSMENT General disorders None View
Generalized itching NON_SYSTEMATIC_ASSESSMENT General disorders None View
Generalized neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
GERD NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GI Upset NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hangover symptoms with associated nausea and vomiting NON_SYSTEMATIC_ASSESSMENT General disorders None View
Head cold NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Heavy menstrual bleeding NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Herpes Zoster (Shingles) NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Itchy right ear NON_SYSTEMATIC_ASSESSMENT General disorders None View
Impacted wisdom tooth NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Infection of the throat NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Inflammation NON_SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Jolting sensation of whole body NON_SYSTEMATIC_ASSESSMENT General disorders None View
Knee pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Left hip/groin pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Left middle finger smashed NON_SYSTEMATIC_ASSESSMENT General disorders None View
Low grade headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Lower back muscle pull NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Mould infection (mouth) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nasal allergies NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nightmares NON_SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Obesitas NON_SYSTEMATIC_ASSESSMENT General disorders None View
Otitis media with effusion NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Pain after tooth extraction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain below right shoulder NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain in esophagus NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain in right ear NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain in shoulder NON_SYSTEMATIC_ASSESSMENT General disorders None View
Painful back muscles NON_SYSTEMATIC_ASSESSMENT General disorders None View
Painful big toe NON_SYSTEMATIC_ASSESSMENT General disorders None View
Painful hip NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Painful right arm NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Painful right index finger NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Personal and work related problems NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Problems with jaw joint NON_SYSTEMATIC_ASSESSMENT General disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Prostatism NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Restless legs NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Right shoulder arm pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Right thigh hematoma NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sciatic nerve aggravated NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sinus infection NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sinus/allergy symptoms NON_SYSTEMATIC_ASSESSMENT General disorders None View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Soft tissue pain; back/ribs NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Stiff neck pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Stress NON_SYSTEMATIC_ASSESSMENT General disorders None View
Stuffy nose NON_SYSTEMATIC_ASSESSMENT General disorders None View
Submandibular gland pain NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
TBI with no LOC NON_SYSTEMATIC_ASSESSMENT General disorders None View
Throat ache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Throat infection NON_SYSTEMATIC_ASSESSMENT General disorders None View
Throat pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Throat tightness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tinnitus NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tongue biting NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tongue hematoma NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tongue pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tooth ache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tooth infection NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tooth removed NON_SYSTEMATIC_ASSESSMENT General disorders None View
Torticollis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Trigger fingers NON_SYSTEMATIC_ASSESSMENT General disorders None View
Type ll Diabetes NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Umbilical hernia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vaginal dermititis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vertigo NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Worsening arrhythmia - bigeminy NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Worsening occasional difficulty with speech NON_SYSTEMATIC_ASSESSMENT General disorders None View
Worsening dry mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
Worsening urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Worsening RLS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Worsening sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wound on top of thumb NON_SYSTEMATIC_ASSESSMENT General disorders None View
Events specifically related to an incision NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Post-operative discomfort independent of any surgical incision NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Procedure related Infection (mild or moderate) NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Discomfort due to electrical stimulation NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tongue abrasion NON_SYSTEMATIC_ASSESSMENT General disorders None View
Mouth dryness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Mechanical pain associated with presence of device NON_SYSTEMATIC_ASSESSMENT General disorders None View
Temporary internal device usability or functionality complaint NON_SYSTEMATIC_ASSESSMENT Investigations None View
Temporary external device usability or functionality NON_SYSTEMATIC_ASSESSMENT Investigations None View
Other acute symptoms NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Device related infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal incisional pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal pain/faecal incontinence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abnormal pap smear/HPV NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Abnormal x-ray NON_SYSTEMATIC_ASSESSMENT General disorders None View
Acid reflux NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute gastro-enteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute prostatitis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Allgeric reaction to Diamox NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Allergic reaction to post-op antibiotics NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Awakening from sleep gasping for air NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Back ache NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Benign fibrous papule and chronic folliculitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bilateral swelling of neck NON_SYSTEMATIC_ASSESSMENT General disorders None View
Blood in ejaculate NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Blood in sputum NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bone spurs NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
BPH NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Broken teeth NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Burning, pinching, mildly tender at IPG site NON_SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Common cold NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cytomegalovirus NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Device stimulation not felt during the night NON_SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Difficulty voiding NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Temporary tongue weakness NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Intubation Effects NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Post-op Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other post-op symptoms NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View