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 |
|---|---|---|---|---|---|---|---|---|
| Placebo Capsules | * Two doses of placebo, instead of FMT: one starting within four (4) days from the start of the conditioning regimen prior to HCT and the second one starting within 4 weeks after engraftment after HCT. * A standard dose of oral Placebo is 15 capsules per day for two consecutive days, Placebo: a harmless pill, medicine, or procedure prescribed more for the psychological benefit to the patient than for any physiological effect. | 1 | None | 0 | 3 | 3 | 3 | View |
| FMT Capsules | * Two doses of FMT: one standard dose starting within four (4) days from the start of the conditioning regimen prior to HCT and one non-standard dose starting within 4 weeks after engraftment after HCT. * A standard dose of oral FMT is 15 capsules per day for two consecutive days, FMT: FMT is a process utilizing microbial components which are the good, healthy bacteria that would otherwise naturally occur in the body. | 2 | None | 1 | 3 | 3 | 3 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Skin ulceration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |