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 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 12:28 AM
NCT ID:
NCT02374060
Description:
None
Frequency Threshold:
2
Time Frame:
24 weeks of follow-up
Study:
NCT02374060
Study Brief:
PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Intravitreal Triamcinolone 4mg | (preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0 Second injection permitted at Week 8 IF: * Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement; * IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Intravitreal triamcinolone 4 mg: Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection. | 0 | None | 5 | 63 | 0 | 63 | View |
| Periocular Triamcinolone 40mg | Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0 Second injection permitted at Week 8 IF: * Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement; * IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Periocular triamcinolone 40 mg: Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed. | 0 | None | 6 | 65 | 0 | 65 | View |
| Dexamethasoneintravitreal Implant | Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0 Second injection permitted at Week 12 IF: * Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement; * IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections. | 0 | None | 6 | 64 | 0 | 64 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Choroidal | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (18.1) | View |
| Ocular hypertension | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (18.1) | View |
| uveitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (18.1) | View |
| Vitreous haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (18.1) | View |
| colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| gastric polyps | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| injection site injury | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Intraocular pressure increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.1) | View |
| mediastinoscopy | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.1) | View |
| bursitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| chronic obstructive pulmonary disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | View |
| pulmonary hypertension | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | View |
| knee arthroplasty | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (18.1) | View |
| shoulder arthroplasty | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (18.1) | View |
| Investigation | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.1) | View |
Other Events(If Any):