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 |
|---|---|---|---|---|---|---|---|---|
| Intent-To-Treat Patients | Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m\^2 IV on days -9 through -5, melphalan 140 mg/m\^2 IV on day -4 and Total Body Irradiation with Marrow Boosting \[ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure\] by Volumetric-Modulated Arc Therapy \[VMAT\] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor. Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8 Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9 | None | None | 0 | 3 | 3 | 3 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hearing loss | None | Ear and labyrinth disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Vomiting | None | Gastrointestinal disorders | None | View |
| Mucositis | None | Gastrointestinal disorders | None | View |
| Acid reflux | None | Gastrointestinal disorders | None | View |
| Fever | None | General disorders | None | View |
| Positive blood culture - Staphylococcus aureus | None | Infections and infestations | None | View |
| Positive blood culture - Escherichia coli | None | Infections and infestations | None | View |
| Adenoviremia | None | Infections and infestations | None | View |
| Acute radiation syndrome | None | Injury, poisoning and procedural complications | None | View |
| Elevated lipase | None | Investigations | None | View |
| Serum amylase increased | None | Investigations | None | View |
| Hypogammaglobulinemia | None | Investigations | None | View |
| Elevated ALT | None | Investigations | None | View |
| Anorexia | None | Metabolism and nutrition disorders | None | View |
| Dizziness | None | Nervous system disorders | None | View |
| Muscle spasms | None | Nervous system disorders | None | View |
| Headache | None | Nervous system disorders | None | View |
| Agitation | None | Psychiatric disorders | None | View |
| Dysuria | None | Renal and urinary disorders | None | View |
| Decreased oxygen saturation | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Rash | None | Skin and subcutaneous tissue disorders | None | View |
| Hypotension | None | Vascular disorders | None | View |
| Fever | None | Infections and infestations | None | View |
| BK viruria | None | Infections and infestations | None | View |
| Decreased vision | None | Eye disorders | None | View |
| Abdominal pain | None | Gastrointestinal disorders | None | View |
| Loose stools | None | Gastrointestinal disorders | None | View |
| Graft failure | None | Injury, poisoning and procedural complications | None | View |
| Elevated AST | None | Investigations | None | View |
| Anxiety | None | Psychiatric disorders | None | View |
| Hypertension | None | Vascular disorders | None | View |