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 @ 12:10 AM
Ignite Modification Date: 2025-12-25 @ 10:10 PM
NCT ID: NCT04957758
Description: Participant population in the Adverse Events section is the safety population. There was 1 subject that was randomized to the placebo group, however was enrolled in error and not treated. Therefore total number of subjects enrolled is 113 but total treated is 112. Additionally, subjects were analyzed based on randomization, however 1 subject in the placebo group received an active treatment kit so therefore total number randomized to OC-01 is 53 but total treated is 54.
Frequency Threshold: 0
Time Frame: Adverse Events were collected at the time of informed consent until the last study visit at 6 months.
Study: NCT04957758
Study Brief: Phase 2 Clinical Trial to Evaluate OC-01 Nasal Spray in Subjects With Neurotrophic Keratopathy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
OC-01 (Varenicline) Nasal Spray, 1.2 mg/mL OC-01 (varenicline) nasal spray, 1.2 mg/mL OC-01 (varenicline) nasal spray 1.2 mg/ml: OC-01 0 None 5 54 39 54 View
Placebo (Vehicle Control) Nasal Spray Placebo (vehicle control) nasal spray Placebo (vehicle) nasal spray: Placebo (vehicle) 0 None 3 58 34 58 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Large Intestinal Obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infective Exacerbation of bronchiectasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Femur Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Renal Neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Corneal Dystrophy SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Asthenopia SYSTEMATIC_ASSESSMENT Eye disorders None View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal Degeneration SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctivochalasis SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal epithelium defect SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal erosion SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal neovascularisation SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal Opacity SYSTEMATIC_ASSESSMENT Eye disorders None View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry Eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Erythema of eyelid SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye Discharge SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye Irritation SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye Pain SYSTEMATIC_ASSESSMENT Eye disorders None View
Lacrimation Increased SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye Swelling SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Large Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Instillation Site Exfoliation SYSTEMATIC_ASSESSMENT General disorders None View
Instillation Site Irritation SYSTEMATIC_ASSESSMENT General disorders None View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis escherichia coli SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpes Zoster SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vulvovaginal mycotic infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ligament Sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Muscle Strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Heart Rate Increased SYSTEMATIC_ASSESSMENT Investigations None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rheumatoid Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Carpal Tunnel Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cervical Radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transient Ischaemic Attack SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hypertonic Bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vulvovaginal dryness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal dryness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal Inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal mucosal disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal Oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Throat Irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper-airway cough syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Trichorrhexis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Meibomian Gland Dysfunction SYSTEMATIC_ASSESSMENT Eye disorders None View
Ocular Hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders None View
Punctate Keratitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Vision Blurred SYSTEMATIC_ASSESSMENT Eye disorders None View
Visual Acuity Reduced SYSTEMATIC_ASSESSMENT Eye disorders None View
Vitreous Floaters SYSTEMATIC_ASSESSMENT Eye disorders None View
Disease Progression SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Conjunctivitis SYSTEMATIC_ASSESSMENT General disorders None View
Erythema of eyelid SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View