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 @ 11:31 PM

Ignite Modification Date: 2025-12-25 @ 9:18 PM

NCT ID: NCT02267356

Description: Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects.

Frequency Threshold: 0

Time Frame: None

Study: NCT02267356

Study Brief: A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail

Event Groups(If Any):

Event Groups

Title	Description	Deaths # Affected	Deaths # At Risk	Serious # Affected	Serious # At Risk	Other # Affected	Other # At Risk	View

Low Dose 12-week	Loading doses of VT-1161 300mg once daily for 2 weeks, then 300mg once weekly for 10 weeks, followed by placebo for 12 weeks	None	None	1	53	29	53	View
Low Dose 24-week	Loading doses of VT-1161 300mg once daily for 2 weeks, then 300mg once weekly for 22 weeks	None	None	1	53	26	53	View
High Dose 12-week	Loading doses of VT-1161 600mg once daily for 2 weeks, then 600mg once weekly for 10 weeks, followed by placebo for 12 weeks	None	None	2	52	31	52	View
High Dose 24-week	Loading doses of VT-1161 600mg once daily for 2 weeks, then 600mg once weekly for 22 weeks	None	None	5	54	36	54	View
Placebo	Matching placebo tablets for 24 weeks	None	None	2	47	26	47	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Hemorrhagic anemia	None	Blood and lymphatic system disorders	None	View
Enterovesical fistula	None	Gastrointestinal disorders	None	View
Chest pain	None	General disorders	None	View
Pyrexia	None	General disorders	None	View
Appendicitis	None	Infections and infestations	None	View
Lower limb fracture	None	Injury, poisoning and procedural complications	None	View
Osteoarthritis	None	Musculoskeletal and connective tissue disorders	None	View
Acoustic neuroma	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Breast cancer	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Depression	None	Psychiatric disorders	None	View
Nephrolithiasis	None	Renal and urinary disorders	None	View
Renal failure acute	None	Renal and urinary disorders	None	View
Postmenopausal hemmorage	None	Reproductive system and breast disorders	None	View
Pulmonary embolism	None	Respiratory, thoracic and mediastinal disorders	None	View
Artery dissection	None	Vascular disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Folliculitis	None	Infections and infestations	None	View
Gastroenteritis	None	Infections and infestations	None	View
Gastroenteritis viral	None	Infections and infestations	None	View
Helicobacter infection	None	Infections and infestations	None	View
Influenza	None	Infections and infestations	None	View
Nasopharyngitis	None	Infections and infestations	None	View
Otitis externa	None	Infections and infestations	None	View
Otitis media	None	Infections and infestations	None	View
Paronychia	None	Infections and infestations	None	View
Pharyngitis streptococcal	None	Infections and infestations	None	View
Pneumonia	None	Infections and infestations	None	View
Ligament rupture	None	Injury, poisoning and procedural complications	None	View
Acute sinusitis	None	Infections and infestations	None	View
Bronchitis	None	Infections and infestations	None	View
Cystitis	None	Infections and infestations	None	View
Diverticulitis	None	Infections and infestations	None	View
Decreased appetite	None	Metabolism and nutrition disorders	None	View
Gout	None	Metabolism and nutrition disorders	None	View
Hypercholesterolemia	None	Metabolism and nutrition disorders	None	View
Hyperglycemia	None	Metabolism and nutrition disorders	None	View
Hyperlipidemia	None	Metabolism and nutrition disorders	None	View
Hyperesthesia	None	Nervous system disorders	None	View
Lethargy	None	Nervous system disorders	None	View
Migraine	None	Nervous system disorders	None	View
Tachycardia	None	Cardiac disorders	None	View
Ventricular extrasystoles	None	Cardiac disorders	None	View
Congenital aural fistula	None	Congenital, familial and genetic disorders	None	View
Ear discomfort	None	Ear and labyrinth disorders	None	View
Middle ear inflammation	None	Ear and labyrinth disorders	None	View
Tinnitus	None	Ear and labyrinth disorders	None	View
Vertigo	None	Ear and labyrinth disorders	None	View
Autoimmune thyroiditis	None	Endocrine disorders	None	View
Conjunctivitis	None	Eye disorders	None	View
Dry eye	None	Eye disorders	None	View
Meibomian gland dysfunction	None	Eye disorders	None	View
Vision blurred	None	Eye disorders	None	View
Abdominal discomfort	None	Gastrointestinal disorders	None	View
Abdominal hernia	None	Gastrointestinal disorders	None	View
Abdominal mass	None	Gastrointestinal disorders	None	View
Abdominal pain	None	Gastrointestinal disorders	None	View
Abdominal pain lower	None	Gastrointestinal disorders	None	View
Abdominal pain upper	None	Gastrointestinal disorders	None	View
Colonic polyp	None	Gastrointestinal disorders	None	View
Constipation	None	Gastrointestinal disorders	None	View
Dental caries	None	Gastrointestinal disorders	None	View
Diarrhea	None	Gastrointestinal disorders	None	View
Diverticulum	None	Gastrointestinal disorders	None	View
Duodenogastric reflux	None	Gastrointestinal disorders	None	View
Dyspepsia	None	Gastrointestinal disorders	None	View
Gastroesophageal reflux disease	None	Gastrointestinal disorders	None	View
Hemorrhoids	None	Gastrointestinal disorders	None	View
Hiatus hernia	None	Gastrointestinal disorders	None	View
Inguinal hernia	None	Gastrointestinal disorders	None	View
Mallory-Weiss syndrome	None	Gastrointestinal disorders	None	View
Nausea	None	Gastrointestinal disorders	None	View
Esophagitis	None	Gastrointestinal disorders	None	View
Rectal hemorrhage	None	Gastrointestinal disorders	None	View
Salivary hypersecretion	None	Gastrointestinal disorders	None	View
Toothache	None	Gastrointestinal disorders	None	View
Vomiting	None	Gastrointestinal disorders	None	View
Asthenia	None	General disorders	None	View
Chest discomfort	None	General disorders	None	View
Chest pain	None	General disorders	None	View
Fatigue	None	General disorders	None	View
Edema peripheral	None	General disorders	None	View
Pain	None	General disorders	None	View
Pyrexia	None	General disorders	None	View
Cholelithiasis	None	Hepatobiliary disorders	None	View
Hypersensitivity	None	Immune system disorders	None	View
Seasonal allergy	None	Immune system disorders	None	View
Pneumonia primary atypical	None	Infections and infestations	None	View
Respiratory tract infection	None	Infections and infestations	None	View
Sinusitis	None	Infections and infestations	None	View
Subcutaneous abscess	None	Infections and infestations	None	View
Tinea pedis	None	Infections and infestations	None	View
Tooth abscess	None	Infections and infestations	None	View
Upper respiratory tract infection	None	Infections and infestations	None	View
Urinary tract infection	None	Infections and infestations	None	View
Viral infection	None	Infections and infestations	None	View
Arthropod bite	None	Injury, poisoning and procedural complications	None	View
Back injury	None	Injury, poisoning and procedural complications	None	View
Burns second degree	None	Injury, poisoning and procedural complications	None	View
Contusion	None	Injury, poisoning and procedural complications	None	View
Excoriation	None	Injury, poisoning and procedural complications	None	View
Eye injury	None	Injury, poisoning and procedural complications	None	View
Face injury	None	Injury, poisoning and procedural complications	None	View
Injury	None	Injury, poisoning and procedural complications	None	View
Joint sprain	None	Injury, poisoning and procedural complications	None	View
Laceration	None	Injury, poisoning and procedural complications	None	View
Ligament injury	None	Injury, poisoning and procedural complications	None	View
Limb injury	None	Injury, poisoning and procedural complications	None	View
Meniscus lesion	None	Injury, poisoning and procedural complications	None	View
Multiple fractures	None	Injury, poisoning and procedural complications	None	View
Muscle injury	None	Injury, poisoning and procedural complications	None	View
Muscle strain	None	Injury, poisoning and procedural complications	None	View
Nail injury	None	Injury, poisoning and procedural complications	None	View
Post concussion syndrome	None	Injury, poisoning and procedural complications	None	View
Procedural nausea	None	Injury, poisoning and procedural complications	None	View
Procedural pain	None	Injury, poisoning and procedural complications	None	View
Tendon injury	None	Injury, poisoning and procedural complications	None	View
Tooth avulsion	None	Injury, poisoning and procedural complications	None	View
Tooth fracture	None	Injury, poisoning and procedural complications	None	View
Traumatic hematoma	None	Injury, poisoning and procedural complications	None	View
Blood cholesterol increased	None	Investigations	None	View
Blood creatine phosphokinase increased	None	Investigations	None	View
Blood pressure increased	None	Investigations	None	View
Blood testosterone decreased	None	Investigations	None	View
Electrocardiogram abnormal	None	Investigations	None	View
Electrocardiogram change	None	Investigations	None	View
Weight decreased	None	Investigations	None	View
Hypertriglyceridemia	None	Metabolism and nutrition disorders	None	View
Arthralgia	None	Musculoskeletal and connective tissue disorders	None	View
Back pain	None	Musculoskeletal and connective tissue disorders	None	View
Bunion	None	Musculoskeletal and connective tissue disorders	None	View
Bursitis	None	Musculoskeletal and connective tissue disorders	None	View
Flank pain	None	Musculoskeletal and connective tissue disorders	None	View
Gouty arthritis	None	Musculoskeletal and connective tissue disorders	None	View
Intervertebral disc protrusion	None	Musculoskeletal and connective tissue disorders	None	View
Joint range of motion decreased	None	Musculoskeletal and connective tissue disorders	None	View
Muscle spasms	None	Musculoskeletal and connective tissue disorders	None	View
Muscle tightness	None	Musculoskeletal and connective tissue disorders	None	View
Muscular weakness	None	Musculoskeletal and connective tissue disorders	None	View
Musculoskeletal pain	None	Musculoskeletal and connective tissue disorders	None	View
Musculoskeletal stiffness	None	Musculoskeletal and connective tissue disorders	None	View
Myalgia	None	Musculoskeletal and connective tissue disorders	None	View
Neck pain	None	Musculoskeletal and connective tissue disorders	None	View
Osteoarthritis	None	Musculoskeletal and connective tissue disorders	None	View
Osteopenia	None	Musculoskeletal and connective tissue disorders	None	View
Pain in extremity	None	Musculoskeletal and connective tissue disorders	None	View
Plantar fasciitis	None	Musculoskeletal and connective tissue disorders	None	View
Sacroiliitis	None	Musculoskeletal and connective tissue disorders	None	View
Spinal column stenosis	None	Musculoskeletal and connective tissue disorders	None	View
Tendonitis	None	Musculoskeletal and connective tissue disorders	None	View
Basal cell carcinoma	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Dysplastic naevus	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Lung neoplasm	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Melanocytic naevus	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Skin papilloma	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Thyroid neoplasm	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Uterine leiomyoma	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
7th nerve paralysis	None	Nervous system disorders	None	View
Autonomic nervous system imbalance	None	Nervous system disorders	None	View
Balance disorder	None	Nervous system disorders	None	View
Disturbance in attention	None	Nervous system disorders	None	View
Dizziness	None	Nervous system disorders	None	View
Dysgeusia	None	Nervous system disorders	None	View
Dyskinesia	None	Nervous system disorders	None	View
Headache	None	Nervous system disorders	None	View
Neuropathy peripheral	None	Nervous system disorders	None	View
Paresthesia	None	Nervous system disorders	None	View
Polyneuropathy	None	Nervous system disorders	None	View
Sinus headache	None	Nervous system disorders	None	View
Somnolence	None	Nervous system disorders	None	View
Tremor	None	Nervous system disorders	None	View
Depression	None	Psychiatric disorders	None	View
Hematuria	None	Renal and urinary disorders	None	View
Nephrolithiasis	None	Renal and urinary disorders	None	View
Pollakiuria	None	Renal and urinary disorders	None	View
Polyuria	None	Renal and urinary disorders	None	View
Urinary incontinence	None	Renal and urinary disorders	None	View
Urine abnormality	None	Renal and urinary disorders	None	View
Benign prostatic hyperplasia	None	Reproductive system and breast disorders	None	View
Prostatomegaly	None	Reproductive system and breast disorders	None	View
Uterine polyp	None	Reproductive system and breast disorders	None	View
Cough	None	Respiratory, thoracic and mediastinal disorders	None	View
Dyspnea	None	Respiratory, thoracic and mediastinal disorders	None	View
Nasal congestion	None	Respiratory, thoracic and mediastinal disorders	None	View
Nasal obstruction	None	Respiratory, thoracic and mediastinal disorders	None	View
Nasal turbinate hypertrophy	None	Respiratory, thoracic and mediastinal disorders	None	View
Oropharyngeal pain	None	Respiratory, thoracic and mediastinal disorders	None	View
Pleurisy	None	Respiratory, thoracic and mediastinal disorders	None	View
Rhinitis seasonal	None	Respiratory, thoracic and mediastinal disorders	None	View
Rhinorrhea	None	Respiratory, thoracic and mediastinal disorders	None	View
Sinus congestion	None	Respiratory, thoracic and mediastinal disorders	None	View
Sleep apnea syndrome	None	Respiratory, thoracic and mediastinal disorders	None	View
Actinic keratosis	None	Skin and subcutaneous tissue disorders	None	View
Blister	None	Skin and subcutaneous tissue disorders	None	View
Dermatitis	None	Skin and subcutaneous tissue disorders	None	View
Dermatitis allergic	None	Skin and subcutaneous tissue disorders	None	View
Dermatitis atopic	None	Skin and subcutaneous tissue disorders	None	View
Dermatitis contact	None	Skin and subcutaneous tissue disorders	None	View
Dry skin	None	Skin and subcutaneous tissue disorders	None	View
Eczema asteatotic	None	Skin and subcutaneous tissue disorders	None	View
Hyperkeratosis	None	Skin and subcutaneous tissue disorders	None	View
Ingrowing nail	None	Skin and subcutaneous tissue disorders	None	View
Neurodermatitis	None	Skin and subcutaneous tissue disorders	None	View
Onychoclasis	None	Skin and subcutaneous tissue disorders	None	View
Onycholysis	None	Skin and subcutaneous tissue disorders	None	View
Rash	None	Skin and subcutaneous tissue disorders	None	View
Rosacea	None	Skin and subcutaneous tissue disorders	None	View
Scar	None	Skin and subcutaneous tissue disorders	None	View
Skin exfoliation	None	Skin and subcutaneous tissue disorders	None	View
Hot flush	None	Vascular disorders	None	View
Hypertension	None	Vascular disorders	None	View