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 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
NCT ID:
NCT04235660
Description:
None
Frequency Threshold:
0
Time Frame:
adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.
Study:
NCT04235660
Study Brief:
Y90 Radiation Segmentectomy vs SBRT for HCC
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Yttrium-90 Radiation Segmentectomy | Yttrium-90 Radiation Segmentectomy: This therapy arm involves two separate steps, a planning/mapping arteriogram and a therapy delivery. The planning arteriogram will be performed to confirm arterial anatomy is acceptable for RS (≤2 segment delivery) and that lung shunting is not too high to preclude treatment with RS. Once confirmed, patients will return for RS (within 45 days of mapping). Dose will be calculated based off the desired treatment volume using pre-treatment cross-sectional imaging. The desired segmental dose will be calculated to be ≥ 200Gy. RS will be performed by one of three separate interventional radiologists with experience in radioembolization. Actual administered activity and location of dose administration will be recorded. | 0 | None | 0 | 1 | 1 | 1 | View |
| Stereotactic Body Radiation Therapy | Stereotactic Body Radiation Therapy: SBRT will be delivered with linear accelerator-based photon beams with either fixed angle non- coplanar fields or dynamic arcs. An internal target volume (ITV) will be generated to account for tumor movement during breathing cycle. Finally, a planning target volume (PTV) will be an expansion of 3- 5mm from the ITV. For Child Pugh A patients, prescription dose will either be 5000cGy in 5 fractions delivered every other day or 4800cGy in 3 fractions delivered twice weekly. For Child Pugh B patients, prescription dose of 4000cGy in 5 fractions delivered every other day. Inverse planning will be used. 95% of the PTV or more will receive at least 100% of the prescription dose. Normal tissue dose constraints for each dose level will be respected with acceptable deviations permitted as outlined in appendix VII. Patients will be seen at least once per week by a clinician to grade toxicities, with on- treatment labs (CBC, CMP, INR) each week. | 0 | None | 0 | 1 | 1 | 1 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| elevated AFP | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| high anion gap | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| glucose intolerance | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| increased size of left renal mass | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| decreased lymphocyte count | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| right leg bruise | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| elevated vitamin D | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| elevated AST | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| low serum carbon dioxide | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| decreased lymphocyte count | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| decreased platelet count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| ALT increased | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| perirectal abscess | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| low sodium | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| decreased lymphocyte count | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| low creatinine | SYSTEMATIC_ASSESSMENT | General disorders | None | View |