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 @ 11:15 PM
Ignite Modification Date:
2025-12-25 @ 8:52 PM
NCT ID:
NCT06041256
Description:
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
Frequency Threshold:
5
Time Frame:
From first dose (Day 1) through Month 12
Study:
NCT06041256
Study Brief:
A Phase 1/2 Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Y-27632 100 µM | Participants received a single intracameral injection of Y-27632 (100 Micromolar \[μM\]) under local anesthesia. | 0 | None | 1 | 21 | 9 | 21 | View |
| Neltependocel 1.0 × 10^6 | Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells under local anesthesia. | 0 | None | 1 | 18 | 11 | 18 | View |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 5.0 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia. | 0 | None | 0 | 19 | 18 | 19 | View |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 2.5 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia. | 0 | None | 0 | 19 | 10 | 19 | View |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells administered with Y-27632 100 μM under local anesthesia. | 0 | None | 0 | 20 | 14 | 20 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ocular hypertension | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Conjunctival haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Corneal epithelium defect | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Eye pain | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Dry eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Punctate keratitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Detached Descemet's membrane | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Eye irritation | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Iridocele | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Iridocyclitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Iris adhesions | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Keratitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Posterior capsule opacification | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Retinal vein occlusion | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Chalazion | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Corneal abrasion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Burns second degree | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Femur fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Ecchymosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.1) | View |
| Skin irritation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.1) | View |
| Knee arthroplasty | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (26.1) | View |
| Tooth extraction | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (26.1) | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Bladder cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.1) | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.1) | View |
| Blood cholesterol increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.1) | View |
| Obesity | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (26.1) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (26.1) | View |
| Macular oedema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Corneal degeneration | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Epiretinal membrane | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Corneal oedema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Endocrine ophthalmopathy | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Ulcerative keratitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Wound dehiscence | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Abdominal hernia repair | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (26.1) | View |
| Rotator cuff repair | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (26.1) | View |
| Malignant melanoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | View |
| Micturition urgency | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (26.1) | View |