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 @ 5:50 PM
Ignite Modification Date:
2025-12-25 @ 3:16 PM
NCT ID:
NCT03982368
Description:
More specifically, adverse events are assessed at Screening day, Visit 1 Day 1), Visit 2 (Day 14), Visit 3 (Day 28), Visit 4 (Day 56), Visit 5 (Day 84), Visit 6 (Day 112).
Frequency Threshold:
1
Time Frame:
From Screening day to week 16
Study:
NCT03982368
Study Brief:
A Study to Evaluate Safety and Efficacy of rhNGF Eye Solution vs Vehicle in Patients With Moderate to Severe Dry Eye
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| rhNGF 20 μg/ml TID - Treatment Period | One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours) rhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours) | 0 | None | 0 | 85 | 65 | 85 | View |
| rhNGF 20 μg/ml BID + Vehicle OD - Treatment Period | One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours) rhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours). rhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon. | 0 | None | 0 | 84 | 60 | 84 | View |
| Vehicle TID - Treatment Period | Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours) Vehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours) | 0 | None | 0 | 88 | 26 | 88 | View |
| rhNGF 20 μg/ml TID - Follow-up Period | One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours) rhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours) | 0 | None | 1 | 85 | 19 | 85 | View |
| Vehicle TID - Follow up Period | Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours) Vehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours) | 0 | None | 1 | 88 | 18 | 88 | View |
| rhNGF 20 μg/ml BID + Vehicle OD - Follow-up Period | One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours) rhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours). rhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon. | 0 | None | 0 | 84 | 19 | 84 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 21.1 | View |
| Asthenopia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Blepharitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Blepharospasm | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Chalazion | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Conjunctival Disorder | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Conjunctival Haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Conjunctival Hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Diplopia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Dry Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Erythema Of Eyelid | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Eye Allergy | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Eye Discharge | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Eye Disorder | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Eye Irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Eye Pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Eye Pruritus | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Eye Swelling | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Eyelid Disorder | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Eyelid Irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Eyelid Oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Eyelid Pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Foreign Body Sensation In Eyes | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Lacrimation Increased | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Meibomian Gland Dysfunction | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Ocular Discomfort | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Ocular Hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Posterior Capsule Opacification | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Refraction Disorder | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Swelling Of Eyelid | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Vision Blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Visual Acuity Reduced | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Visual Impairment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Vitreous Floaters | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Inguinal Hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Instillation Site Irritation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Instillation Site Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Hordeolum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Kidney Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Upper Respiratory Tract | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Viral Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Back Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Humerus Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Ligament Sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Superficial Injury Of Eye | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Bursitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Tendonitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Migraine With Aura | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Bladder Prolapse | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 21.1 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Oropharyngeal Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Sinus Congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Throat Irritation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Hot Flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.1 | View |
| Lymphoedema | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.1 | View |