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 @ 12:14 PM
Ignite Modification Date:
2025-12-25 @ 12:01 PM
NCT ID:
NCT02921061
Description:
None
Frequency Threshold:
0
Time Frame:
All-Cause Mortality assessed for up to 12 months; Serious and Other Adverse Events assessed for up to 1 month after treatment duration of about 10 days concluded
Study:
NCT02921061
Study Brief:
Decitabine With GCLAM for Adults With Newly Diagnosed, Relapsed, or Refractory AML or High-Risk MDS
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Treatment (Decitabine 20 mg/m2 and G-CLAM) | Patients receive induction therapy comprising decitabine IV over 1 hour (20 mg/m2) on days 1-10 and G-CLAM (filgrastim SC on days 0-5, cladribine IV over 2 hours on days 1-5, cytarabine IV over 2-4 hours on days 1-5, and mitoxantrone IV over 60 minutes on days 1-3). Patients who do not achieve MRDneg CR after first induction are eligible for re-induction with G-CLAM. Beginning 6 weeks after achieving MRDneg CR or CR/CR with CRi after induction and/or re-induction, patients are eligible to receive consolidation therapy comprising GLCA (filgrastim, cladribine, cytarabine) for up to 4 cycles. Subsequent consolidation cycles would be given after recovery from the previous cycle (roughly 4-6 weeks). | 19 | None | 2 | 28 | 28 | 28 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| acute kidney injury, grade 3 | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| aortic valve disease, grade 3 | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| AST increased, grade 3 | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| atrial fibrillation, grade 3 | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| atrial fibrillation, grade 4 | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| back pain, grade 3 | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| delirium, grade 3 | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| diarrhea, grade 3 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| duodenal hemorrhage, grade 4 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| dyspnea, grade 4 | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| encephalopathy, grade 4 | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| fatigue, grade 3 | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| febrile neutropenia, grade 3 | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| hyperbilirubinemia, grade 4 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| hypertension, grade 3 | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| hypokalemia, grade 3 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| hypotension, grade 3 | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| hypoxemia, grade 3 | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| infective endocarditis, grade 3 | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| LV systolic dysfunction, grade 4 | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| maculopapular rash, grade 3 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| myocardial infarction, grade 4 | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| nausea, grade 3 | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| phlebitis infective, grade 3 | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| pleural effusions, grade 3 | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| pulmonary nodules, grade 3 | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| sinusitis, grade 3 | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| syncope, grade 3 | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| tumor lysis syndrome, grade 3 | SYSTEMATIC_ASSESSMENT | General disorders | None | View |