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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:57 PM
NCT ID:
NCT04391894
Description:
All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Frequency Threshold:
0
Time Frame:
Up to 28 days (Baseline (BL) to end of randomized treatment)
Study:
NCT04391894
Study Brief:
A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| ECF843 0.45 mg/mL TID (Part 1) | ECF843 0.45 mg/mL ter in die/three times a day (TID) (Part 1) | 0 | None | 0 | 111 | 9 | 111 | View |
| ECF843 0.15 mg/mL TID (Part 1) | ECF843 0.15 mg/mL ter in die/three times a day (TID) (Part 1) | 0 | None | 0 | 112 | 15 | 112 | View |
| ECF843 Vehicle TID (Part 1) | ECF843 vehicle ter in die/three times a day (TID) (Part 1) | 0 | None | 1 | 112 | 5 | 112 | View |
| ECF843 0.15 mg/mL BID (Part 1) | ECF843 0.15 mg/mL bis in diem/twice a day (BID) (Part 1) | 0 | None | 0 | 109 | 5 | 109 | View |
| ECF843 Vehicle BID (Part 1) | ECF843 vehicle bis in diem/twice a day (BID) (Part 1) | 0 | None | 1 | 114 | 12 | 114 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (24.0) | View |
| Blepharitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| Chalazion | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| Conjunctival deposit | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| Conjunctival hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| Corneal erosion | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| Eye irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| Eye pruritus | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| Eyelids pruritus | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| Foreign body sensation in eyes | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| Glare | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| Lacrimation increased | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| Ocular hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| Visual acuity reduced | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| Instillation site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Hordeolum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Infected bite | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Pharyngitis streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| Cartilage injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| Corneal abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| Foreign body in eye | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| Muscle injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |