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 @ 3:07 PM
Ignite Modification Date:
2025-12-25 @ 1:28 PM
NCT ID:
NCT03680092
Description:
None
Frequency Threshold:
5
Time Frame:
1 year
Study:
NCT03680092
Study Brief:
Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cyclophosphamide and Abatacept | The GVHD prophylaxis regimen on the experimental arm will consist of high dose Cyclophosphamide on Days +3 and +4 followed by abatacept for 6 months. Abatacept at a dose of 10mg/kg will be administered on days +5, +14 and +28, +56, +84, +112, +140, +168 Cyclophosphamide: Day 3 and day 4 following transplant. Dosing will be based on patients' actual weight up to 120% of ideal body weight, above which it will be based on adjusted ideal body weight (ideal weight plus 50% of the difference between ideal and actual weight). abatacept: Abatacept at a dose of 10mg/kg will be administered on days +5, +14 and +28, +56, +84, +112, +140, +168 | 2 | None | 9 | 25 | 5 | 25 | View |
| Methotrexate and Tacrolimus | The GVHD prophylaxis regimen on the standard of care arm will consist of methotrexate on Days +1,+3, +6 and +11 and tacrolimus Methotrexate: standard of care Methotrexate 5 mg/m2 on Days 1, 3, 6 and 11 Tacrolimus: Tacrolimus per institutional guidelines | 3 | None | 13 | 15 | 10 | 15 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| CMV viremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Oral mucositis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Skin rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| hemorrhagic cystitis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| C diff infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| engraftment syndrome | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| HLH | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| hyperbilirubinemiα | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| hyperglycemia | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| hypogammaglobulinemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| hypokalemia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| ischemic colitis and perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| cellulitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| PTLD | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| retinal detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| volume overload | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| CMV Viremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| oral mucositis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| dry eyes | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| BK viremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| EBV viremia | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| TTP | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |