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 @ 11:17 PM
Ignite Modification Date:
2025-12-25 @ 8:56 PM
NCT ID:
NCT04565756
Description:
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
Frequency Threshold:
5
Time Frame:
Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Study:
NCT04565756
Study Brief:
A Study to Evaluate the Safety and Tolerability of EXN407
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 Escalation EXN407 Cohort 1 | Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period. EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only. | 0 | None | 0 | 3 | 2 | 3 | View |
| Dose Escalation EXN407 Cohort 2 | Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period. EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only. | 0 | None | 0 | 3 | 2 | 3 | View |
| Dose Escalation EXN407 Cohort 3 | Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period. EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only. | 0 | None | 0 | 3 | 1 | 3 | View |
| Dose Escalation Pooled Placebo Cohort | Data from the placebo subjects in the 3 dose escalation groups was pooled giving a total of n=4 | 0 | None | 0 | 4 | 1 | 4 | View |
| Dose Expansion EXN407 Cohort | The highest well-tolerated dose of EXN407 will be evaluated where subjects will receive EXN407 at the selected dose or placebo twice a day for up to 84 days resulting in a total of 168 doses EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only. | 0 | None | 2 | 23 | 11 | 23 | View |
| Dose Expansion Placebo Cohort | Dose expansion cohort consisted of subjects randomised to receive EXN407 at the selected dose or placebo (vehicle) at a 2:1 drug: placebo ratio. | 0 | None | 1 | 12 | 9 | 12 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.1 | View |
| non-ST elevation acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.1 | View |
| severe hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Blepharitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.1 | View |
| Posterior capsule opacification | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.1 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.1 | View |
| Eye pruritus | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.1 | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.1 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.1 | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v23.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.1 | View |
| Episcleritis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.1 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | View |
| Gastrointestinal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.1 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.1 | View |
| Visual field defect | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.1 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.1 | View |
| Blood phosphorus decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.1 | View |
| Electrocardiogram ST segment elevation | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.1 | View |
| Punctate keratiis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.1 | View |
| Foreign body sensation in eyes | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.1 | View |
| Cataract cortical | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.1 | View |
| Eye irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.1 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.1 | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.1 | View |
| Acrochordon | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | View |