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 @ 12:42 PM
Ignite Modification Date:
2025-12-25 @ 12:13 PM
NCT ID:
NCT00096161
Description:
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
Frequency Threshold:
0
Time Frame:
AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Study:
NCT00096161
Study Brief:
Pentostatin and Lymphocyte Infusion in Preventing Graft Rejection in Patients Who Have Undergone Donor Stem Cell Transplant
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Group 1A (Pentostatin, DLI Dose Level 1) | Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV | None | None | 6 | 20 | 10 | 20 | View |
| Group 1B (Pentostatin, DLI Dose Level 2) | Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV | None | None | 0 | 10 | 2 | 10 | View |
| Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS) | Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV | None | None | 0 | 6 | 2 | 6 | View |
| Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS) | Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD. Pentostatin: Given IV Therapeutic Allogeneic Lymphocytes: Given IV | None | None | 0 | 0 | 0 | 0 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| GVHD | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Peripheral motor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hemolytic uremic syndrome | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Cardiac troponin I increased | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Forced expiratory volume decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Gastric hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hemolysis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Ileal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Investigations - Other, (Pancytopenia) | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Small intestine infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Thrombotic thrombocytopenic purpura | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | None | View |