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 |
|---|---|---|---|---|---|---|---|---|
| Arm A: Haplo-HCT <55 Years Old | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients \<55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 Haplo HCT \<55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion Day 0 GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) | 6 | None | 6 | 14 | 10 | 14 | View |
| CLOSED Arm B: Haplo-HCT ≥55 Years Old | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. Haplo HCT ≥55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel): Dose reduction by 30% * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) | 13 | None | 9 | 21 | 11 | 21 | View |
| Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and \< 65 years old. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥55 and \< 65 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * non-T-cell depleted donor bone marrow stem cells | 5 | None | 4 | 8 | 6 | 8 | View |
| Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3 | Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Total body irradiation (TBI) | 18 | None | 11 | 35 | 15 | 35 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Serious bacterial Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |