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 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
NCT ID:
NCT03615105
Description:
None
Frequency Threshold:
5
Time Frame:
2 years
Study:
NCT03615105
Study Brief:
Donor Stem Cell Transplantation Using α/β+ T-lymphocyte Depleted Grafts From HLA Mismatched Donors
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Busulfan, Fludarabine & Melphalan | Busulfan: Busulfan (adult/ped dose) Fludarabine: Fludarabine 25 mg/m2 IV Melphalan: Melphalan 70 mg/m2 IV HPC(A) stem cell allograft: All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system. Rituximab: Rituximab 200 mg IV flat dose Rabbit antithymocyte globulin: Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion. | 2 | None | 3 | 5 | 5 | 5 | View |
| Clofarabine, Thiotepa & Melphalan | Thiotepa: Thiotepa 5 mg/kg IV Melphalan: Melphalan 70 mg/m2 IV Clofarabine: Clofarabine 20-30 mg/m2 IV HPC(A) stem cell allograft: All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system. Rituximab: Rituximab 200 mg IV flat dose Rabbit antithymocyte globulin: Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion. | 1 | None | 1 | 1 | 1 | 1 | View |
| Radiation, Thiotepa & Cyclophosphamide | Hyperfractionated total body irradiation: Hyperfractionated TBI is administered by a linear accelerator at a dose rate of \<20 cGy/minute. Doses of 125 cGy/fraction are administered at a minimum interval of 4 hours between fractions, three times/day for a total of 11 or 12 doses (1,375 or 1,500 cGy) over 4 days (days -9 through -6). Thiotepa: Thiotepa 5 mg/kg IV Cyclophosphamide: Cyclophosphamide 60 mg/kg IV HPC(A) stem cell allograft: All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system. Rituximab: Rituximab 200 mg IV flat dose Rabbit antithymocyte globulin: Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion. | 1 | None | 2 | 3 | 3 | 3 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Gastrointestinal disorders, other | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Sinus Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Rash Maculo-Papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Enterocolitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Acute Kidney Injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Lung Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infection and infestations, other | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypermagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Serum amylase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |