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 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
NCT ID:
NCT04276558
Description:
None
Frequency Threshold:
3.7
Time Frame:
Safety assessments were conducted for all patients from the Screening Visit (upon the signature of the ICF) to the end of the study (8 weeks)
Study:
NCT04276558
Study Brief:
REC 0/0559 Eye Drops for Treatment of Moderate and Severe Neurotrophic Keratitis in Adult Patients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Dose 2 - 2.5 µg/Day | Dose of study drug per day: 2.5 µg/day Study drug concentration: 25 µg/mL MT8 given 1 drop QID Udonitrectag: Eye drop solution in single dose unit. Vehicle: Eye drop solution with no active substance in single dose unit. | 1 | None | 3 | 26 | 17 | 26 | View |
| Dose 3 - 5 µg/Day | Dose of study drug per day: 5 µg/day Study drug concentration: 50 µg/mL MT8 given 1 drop QID Udonitrectag: Eye drop solution in single dose unit. Vehicle: Eye drop solution with no active substance in single dose unit. | 0 | None | 7 | 26 | 18 | 26 | View |
| Vehicle | Dose of study drug per day: 0 µg/day Study drug concentration: Vehicle given 1 drop QID Vehicle: Eye drop solution with no active substance in single dose unit. | 0 | None | 4 | 29 | 11 | 29 | View |
| Dose 1 - 0.5 µg/Day | Dose of study drug per day: 0.5 µg/day Study drug concentration: 5 µg/mL MT8 given 1 drop QID Udonitrectag: Eye drop solution in single dose unit. Vehicle: Eye drop solution with no active substance in single dose unit. | 0 | None | 4 | 27 | 18 | 27 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ulcerative keratitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Corneal epithelium defect | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Corneal erosion | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Corneal perforation | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Sudden visual loss | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Herpes ophthalmic | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Hypopyon | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Ophthalmic herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Coronavirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Postoperative wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Wound sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (27.0) | View |
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (27.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.0) | View |
| Iron deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.0) | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (27.0) | View |
| Renal impairment | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (27.0) | View |
| Acute pulmonary oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | View |
| Corneal graft rejection | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (27.0) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | View |
| Intracranial pressure increased | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (27.0) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (27.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (27.0) | View |
| Hypertensive crisis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (27.0) | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (27.0) | View |
| Cardiac failure cogestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (27.0) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (27.0) | View |
| Increased tendency to bruise | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (27.0) | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (27.0) | View |
| Benign neoplasm of skin | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | View |
| Neutrophic keratopathy | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Eye pain | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Ulcerative keratitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Visual acuity reduced | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Conjunctival hyperemia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Corneal oedema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Eye irritation | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Eye pruritus | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Corneal scar | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Foreign body sensation in eyes | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Hypoaesthesia eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Corneal opacity | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Lacrimation increased | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Visual impairment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Coronavirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (27.0) | View |
| Corneal epithelium defect | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Corneal erosion | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Corneal Perforation | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Crystoid macular oedema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Ocular discomfort | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Ocular hyperemia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Photophobia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Vision Blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Vitreous detachment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Vitreous haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Abnormal sensation in the eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Anterior chamber flare | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Conjunctival haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Corneal deposits | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Corneal endothelitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Corneal neovascularisation | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Dellen | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Erythem of the eyelid | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Eye discharge | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Eyelids pruritus | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Keratitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Ocular surface disease | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Punctate keratitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Symblepharon | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Corneal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Hypopyon | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Infective corneal ulcer | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Keratitis bacterial | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Ophthalmic herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Oral herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Wound sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Gamma-glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.0) | View |
| Blood pressure increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.0) | View |
| Blood tryglycerides increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.0) | View |
| Blood urea increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.0) | View |
| lymphocytes count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.0) | View |
| White blood cell count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.0) | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.0) | View |
| Blood calcium increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.0) | View |
| Blood glucose increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.0) | View |
| Heart rate increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.0) | View |
| Monocyte count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.0) | View |
| Neutrophil count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.0) | View |
| Hypercholesterolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.0) | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.0) | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.0) | View |
| Type 2 diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.0) | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (27.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (27.0) | View |
| Instillation site irritation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (27.0) | View |
| instillation site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (27.0) | View |
| Instillation site pruritus | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (27.0) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (27.0) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | View |
| Intracranial pressure increased | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (27.0) | View |
| Metabolic encephalopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (27.0) | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (27.0) | View |
| Inguinal hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.0) | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.0) | View |
| Medication error | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (27.0) | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (27.0) | View |
| Corneal abrasion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (27.0) | View |
| Corneal graft rejection | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (27.0) | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (27.0) | View |
| Acute pulmonary oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | View |
| Acute respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | View |