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 |
|---|---|---|---|---|---|---|---|---|
| Hematopoietic Stem Cell Transplant | Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant. Hematopoietic Stem Cell Transplant: NOTE: The - sign is the number of days before the transplant and the + sign is the number of days after the transplant. * Alemtuzumab 0.2mg/kg Day-14,-13,-12,-11,-10 * Fludarabine 30 mg/m2 on Day -8,-7,-6,-5,-4 * Melphalan 140mg/m2 on Day -3 The GVHD prophylaxis will consist of the following: * Cyclosporine on Day -3 to Day +100, maintaining a level of 250-500 ng/mL, then taper to Day +180. * Methylprednisolone 2 mg/kg/day on Day -2 and -1, 1 mg/kg/day on Day 0 to Day +28, then taper over 1 month. Oral prednisone may be substituted starting on Day 0 (1.2 mg/kg/day) | None | None | 14 | 46 | 0 | 46 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Febrile neutropenia | None | Blood and lymphatic system disorders | MedDRA 20.0 | View |
| Haemolytic anaemia | None | Blood and lymphatic system disorders | MedDRA 20.0 | View |
| Cardiac arrest | None | Cardiac disorders | MedDRA 20.0 | View |
| Ventricular hypertrophy | None | Cardiac disorders | MedDRA 20.0 | View |
| Death | None | General disorders | MedDRA 20.0 | View |
| Serum sickness | None | Immune system disorders | MedDRA 20.0 | View |
| Sepsis | None | Infections and infestations | MedDRA 20.0 | View |
| Post transplant lymphoproliferative disorders | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | View |
| Cerebrovascular accident | None | Nervous system disorders | MedDRA 20.0 | View |
| Haemorrhagic stroke | None | Nervous system disorders | MedDRA 20.0 | View |
| Posterior reversible encephalopathy syndrome | None | Nervous system disorders | MedDRA 20.0 | View |
| Proteinuria | None | Renal and urinary disorders | MedDRA 20.0 | View |
| Respiratory failure | None | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Hypotension | None | Vascular disorders | MedDRA 20.0 | View |