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 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 5:17 PM
NCT ID:
NCT00919503
Description:
Adverse Events were collected 100 days post initiation of conditioning therapy. All-Cause Mortality was assessed through 10.6 years post transplant (through study completion date 6/10/2020).
Frequency Threshold:
0
Time Frame:
Day 100 post initiation of conditioning therapy
Study:
NCT00919503
Study Brief:
Treosulfan and Fludarabine Phosphate Before Donor Stem Cell Transplant in Treating Patients With Nonmalignant Inherited Disorders
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Regimen A (PBSCT and BMT) | CONDITIONING REGIMEN A : Patients receive treosulfan IV on days -6 to -4 and fludarabine phosphate IV on days -6 to -2. Patients receive anti-thymocyte globulin IV on days -4 to -2. Patients undergoing umbilical cord blood transplantation will also receive low dose total-body irradiation on day -1. TRANSPLANTATION: Patients receive either bone marrow, peripheral blood stem cells (PBSC), or umbilical cord blood from the donor on day 0. The use of either bone marrow, PBSC, or umbilical cord blood will depend on the donor status. Patients undergoing bone marrow or PBSC transplantation receive tacrolimus IV continuously or PO twice daily on days -1 to 50 followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. Allogeneic Bone Marrow Transplantation: Infused IV Anti-Thymocyte Globulin: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Methotrexate: Given IV Peripheral Blood Stem Cell Transplantation: Infused IV Tacrolimus: Given IV or PO Treosulfan: Given IV | 7 | None | 17 | 84 | 53 | 84 | View |
| Regimen B (UBCT) | CONDITIONING REGIMEN B: Patients receive treosulfan IV on days -6 to -4 and fludarabine phosphate IV on days -6 to -2. Patients receive anti-thymocyte globulin IV on days -4 to -2. Patients undergoing umbilical cord blood transplantation will also receive low dose total-body irradiation on day -1 . TRANSPLANTATION: Patients receive either bone marrow, peripheral blood stem cells (PBSC), or umbilical cord blood from the donor on day 0. The use of either bone marrow, PBSC, or umbilical cord blood will depend on the donor status. Patients undergoing UCB transplantation receive cyclosporine IV over 1 hour every 8-12 hours on days -3 to 100 followed by a taper until day 180 in the absence of GVHD. Patients also receive mycophenolate mofetil IV or PO every 8 hours on days 0 to 40 followed by a taper until day 96 in the absence of GVHD. Anti-Thymocyte Globulin: Given IV Cyclosporine: Given IV or PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Total-Body Irradiation: Undergo total body irradiation Treosulfan: Given IV Umbilical Cord Blood Transplantation: Single or double unit umbilical cord blood transplant, infused IV | 6 | None | 5 | 14 | 10 | 14 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastrointestinal Other: Pneumatosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Sepsis with multiorgan failure | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Apnea: Requiring intubation following BAL; attributed to underlying infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Anaphylaxis reaction (rATG) | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Cardiac Asystole following central venous catheter placement | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hypotension: requiring intervention | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hypotension: shock, pressors | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhea (associated with GVHD): >15ml/kg per day with abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Fever (not neutropenic): attributed to rATG | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fever (not neutropenic) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Febrile neutropenia: attributed to rATG | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Febrile Neutropenia: with life- threatening sepsis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Infections and infestations -Other, specify: parainfluenza or sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infections and infestations -Other, specify: CMV meningitis/encephalo | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infections and infestations -Other, specify: Clostridium septicum sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Adult respiratory distress syndrome (ARDS) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Acute kidney injury (reversible, requiring CRRT/dialysis) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypoxia: Decreased O2 sat requiring support | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaphylaxis reaction: Possible reaction to rATG | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Pericardial effusion: Tamponade | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Thrombotic microangiopathy (requiring intervention) with acute renal fail: Hemolytic uremic syndrome | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Fluid retention - evidence of ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhea (associated with GVHD): >15ml/kg per day | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gastrointestinal disorders -Other, specify: pneumatosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Oral mucositis: Requiring intervention | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Esophageal ulcers: Presumed viral esophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pulmonary hemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Elevated bilirubin (>3-10x ULN) | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Fever (not neutropenic): attributed to rATG | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fever (not neutropenic) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Infections and infestations -Other, specify: life-threatening disseminated Adenovirus | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| sleep apnea: Obstructive | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypoxia: decreased O2 sat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypoxia: requiring intubation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Adult respiratory distress syndrome (ARDS) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Acute kidney injury (reversible, requiring CRRT/dialysis) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Hemolysis (AIHA): Requiring transfusion and sterioids | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hypotension: requiring intervention | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Cardiopulmonary arrest: Requiring intubation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Thrombotic microangiopathy (not requiring intervention) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Rash (>50%) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Colitis: Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Febrile neutropenia: attributed to rATG | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Dysfunctional urerine (menstrual) bleeding: requiring transfusion | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Oral hemorrhage: Bleeding (requiring transfusion) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| nfections and infestations -Other, specify: MSSA septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infections and infestations -Other, specify: Strep viridans, enterococcus bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Reversible posterior leukoencephalopathy syndrome (PRES) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Seizure (conciousness altered) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Carbon monoxide diffusing capacity decreased (DLCO) | SYSTEMATIC_ASSESSMENT | Investigations | None | View |