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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Tixel Group | Screening and baseline visits, Treatment- 3 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after the last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire. Tixel C: Tixel C by Novoxel®, Israel is a thermomechanical system developed for fractional treatment. The system is designed for the treatment of soft tissue by direct conduction of heat, enabling tissue coagulation combined with micro ablation with low thermal damage to the surrounding tissue. | 0 | None | 4 | 53 | 6 | 53 | View |
| LipiFlow | LipiFlow: Screening and baseline visits,Treatment session, followed by 2 Follow up sessions, 1and 3 months after the last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire. LipiFlow: Thermal pulsation (LipiFlow) consists of the localized application of heat and therapeutic pressure on the four eyelids (upper and lower) with the aim of improving drainage of the Meibomian glands. | 0 | None | 1 | 53 | 4 | 53 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Retinal Detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| Operculated Retinal Hole | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| facial melanoma in situ | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Infectious L5/S1 spondylodiscitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal mass | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Hyprtension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| Mastoiditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (10.0) | View |
| Conjunctival cyst | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| Conjunctivitis allergic | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| Conjunctivitis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Corneal abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |