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 |
|---|---|---|---|---|---|---|---|---|
| Exposed to Methylprednisolone | SARS-CoV-2 positive patients with severe acute respiratory syndrome consecutively treated with methylprednisolone (MP) at prolonged dose. Inclusion criteria checked, the patient undergo 80mg iv bolus of MP followed by infusion (10cc/h) of MP in 240cc 0.9% saline every day until PaO2/FiO2 increase over 350 and/or CRP decrease below 20mg/L, then MP is administered PO tapering slowly until normal CRP values (+20%) are reached. Methylprednisolone: after initial 80mg iv bolus followed by 80mg in 240cc 0.9% saline administered iv at 10cc/h speed for at least 7 day or more. Duration of Methylprednisolone treatment depends from CRP and P/F values already described in arm/group description standard care: usual standard of care: * respiratory support * empiric antibiotic therapy * mechanical ventilation (invasive or noninvasive) * pronation when possible * other treatment which can be used are: antivirals, chloroquine, vitamins | 9 | None | 6 | 83 | 23 | 83 | View |
| Non-exposed to Methylprednisolone | Concurrent patients with the same inclusion/section exclusion criteria never treated with steroids, strictly matched according to gender and age (+/-10 years) and other three parameters: CRP, SOFA score, PaO2:FiO2 -\> each parameter must be \<20% difference between case and control. standard care: usual standard of care: * respiratory support * empiric antibiotic therapy * mechanical ventilation (invasive or noninvasive)pronation when possible * other treatment which can be used are: antivirals, chloroquine, vitamins | 24 | None | 9 | 90 | 21 | 90 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Shock | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Acute renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Disseminated intravascular coagulation | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Acute myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bacterial superinfection | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Agitation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Transaminase elevation | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| QT elongation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |