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 @ 5:16 PM
NCT ID:
NCT00578903
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00578903
Study Brief:
Allogeneic Stem Cell Transplant for Patients With Severe Aplastic Anemia
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Patients | Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member. | None | None | 10 | 22 | 20 | 22 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hematuria (in the absence of vaginal bleeding) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Catheter-Related Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 1 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infection without neutropenia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypocalcemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypophosphatemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Neurology-Other | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Seizure(s) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Rash/desquamation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Rash/desquamation associated with graft versus host disease (GVHD) for BMT studies, if specifi | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhea patients without colostomy | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Stomatitis/Pharyngitis (oral/pharyngeal mucositis) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Alkaline Phosphatase | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Bilirubin | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| GGT (Gamma-Glutamyl transpeptidase) | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Hypoalbuminemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| SGOT (AST) (serum glutamic oxaloacetic transaminase) | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| SGPT (ALT) (serum glutamic pyruvic transaminase) | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Bicarbonate | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypercalcemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypermagnesemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypernatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypertriglyceridemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypomagnesemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypomagnesmia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Abdominal pain or cramping | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain-Other | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Creatinine | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Renal/Genitourinary-Other | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |