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 @ 1:23 AM
Ignite Modification Date: 2025-12-25 @ 11:33 PM
NCT ID: NCT00935493
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00935493
Study Brief: Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Guanfacine 0.5 mg Guanfacine: Guanfacine 0.5 mg None None 1 41 32 41 View
Placebo Placebo: Placebo None None 2 41 34 41 View
Guanfacine 0.1 mg Guanfacine: Guanfacine 0.1 mg None None 2 41 25 41 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Speech impairment/Use of right side NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Non-ST Elevation Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Right Frontal Subarachnoid Hemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest Pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abrasion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Actinic Keratosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bee Stings NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Blister NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bruising NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hair Loss NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Insect Bite NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Laceration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Poison Ivy NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Shingles NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Varicose Veins NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cold Sores NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dental Implants NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dry Socket NON_SYSTEMATIC_ASSESSMENT General disorders None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Infection Post Tooth Extraction NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis Media NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Precancerous Lesion On Tongue NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Rhinorrhea NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sinus Congestion NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sinusitis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sleep Apnea NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sneezing NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sore Throat NON_SYSTEMATIC_ASSESSMENT General disorders None View
Throat Swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Tooth Abscess NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Abdominal Cramps NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Difficulty Swallowing SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diverticulitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Inguinal Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Irregular Bowl Movements SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Allergies SYSTEMATIC_ASSESSMENT General disorders None View
Diaphoresis SYSTEMATIC_ASSESSMENT General disorders None View
Fall SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Night Sweats SYSTEMATIC_ASSESSMENT General disorders None View
Difficuluty Urinating SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diminished Libido SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Uterine Polyp SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Leg Cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Leg Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle Spasm SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle Strain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sciatica SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cognitive Worsening SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ischemic Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lightheadedness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sedation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Subarachnoid Hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cataracts SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Sty SYSTEMATIC_ASSESSMENT Eye disorders None View
Subconjunctival Hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Worsening in Near Vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sadness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Shortness of Breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Low Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View