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 @ 5:09 PM
Ignite Modification Date:
2025-12-25 @ 2:47 PM
NCT ID:
NCT02855450
Description:
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that started on or after the date of the First Study Treatment Administration. An AE was considered as TEAE if the Electronic Case Report Form question 'Did the event occurred:' was answered either with 'During Treatment Period' or 'During Follow-Up Period'.
Frequency Threshold:
0
Time Frame:
Treatment period: Day 0 (Therapy initiation), Day 7, Day 28, Day 56; Follow-up: Day 84, Day 224
Study:
NCT02855450
Study Brief:
Study to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution Versus Vehicle in Patients With Glaucoma
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 | rhNGF (Recombinant Human Nerve Growth Factor) 180 μg/ml eye drops solution rhNGF: Recombinant Human Nerve Growth Factor 180μg/ml (one 35 μl drop equals to 6.30 μg of rhNGF) reconstituted solution three times a day (TID) for 8 weeks of treatment. | 0 | None | 3 | 40 | 31 | 40 | View |
| Vehicle | Ophthalmic Placebo solution Vehicle: Ophthalmic Placebo solution of the same composition as the test product with the exception of rhNGF reconstituted solution times a day (TID) for 8 weeks of treatment. | 0 | None | 2 | 20 | 9 | 20 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 20.0 | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 20.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 20.0 | View |
| Mycobacterium avium complex infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Radius fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 20.0 | View |
| Mycosis fungoides | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | View |
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 20.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 20.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 20.0 | View |
| Aortic stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 20.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Eye irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Conjunctival hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Blepharitis | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Foreign body sensation in eyes | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Lacrimation increased | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Uveitis | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Abnormal sensation in eye | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Blepharochalasis | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Chalazion | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Conjunctival oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Eye inflammation | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Eye swelling | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Eyelid oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Eyelid pain | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Eyelid ptosis | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Keratitis | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Meibonian gland dysfunction | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Ocular discomfort | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Ocular hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Punctate keratitis | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Retinal haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Vitreous haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Haedache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 20.0 | View |
| Intraocular pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Intraocular pressure test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Loer respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 20.0 | View |
| Bowen's disease | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | View |
| Squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | View |
| Medical device implantation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | 20.0 | View |
| Photocoagulation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | 20.0 | View |
| Nasal discomfort | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 20.0 | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 20.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 20.0 | View |
| Iron deficiency anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 20.0 | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | 20.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |