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 |
|---|---|---|---|---|---|---|---|---|
| IV Meropenem; Parenteral Aminoglycoside | Subjects assigned to this group will receive: * IV meropenem (2 g infused over 3 hrs q 8 hr); * a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h) * tobramycin nebulization Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat potential Gram-positive pathogens. IV meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr). Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h: a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h) Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage. tobramycin nebulization: tobramycin nebulization 600mg/day | None | None | 6 | 13 | 0 | 13 | View |
| I.V. Meropenem | Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr). Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat Gram-positive pathogens. \*\*NOTE: Empiric MRSA coverage is allowed in both arms. This therapy is advised for any subjects with known or suspected MRSA entering the study. Once microbiologic results are available, this coverage may be discontinued at the investigator's discretion. I.V. Meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr). Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage. | None | None | 11 | 30 | 0 | 30 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| cutaneous eruption | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| reinforced duodenal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| pneomonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| cardiogenic shock | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| COPD with acute exacerbation | None | Respiratory, thoracic and mediastinal disorders | None | View |
| pneumothorax | None | Respiratory, thoracic and mediastinal disorders | None | View |
| AICD fired/NSTEMI | None | Cardiac disorders | None | View |
| PEA arrest | None | Cardiac disorders | None | View |
| multi-organ failure | None | General disorders | None | View |
| multi-organ failure due to distributive and cardiogenic shock | None | General disorders | None | View |
| stroke | None | General disorders | None | View |
| cardiorespiratory arrest | None | General disorders | None | View |
| pulmonary embolism | None | General disorders | None | View |
| refractory shock | None | General disorders | None | View |
| septic shock | None | General disorders | None | View |