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 |
|---|---|---|---|---|---|---|---|---|
| Hygiene Education | Participants will receive specific hygiene instructions according to existing recommendations from the Ryan White Center for Pediatric Infectious Disease, Riley Hospital as outlined here: * Take daily showers or bath with soap * Clean hands with soap and water or with hand sanitizers when hands are dirty, and after each bathroom break or diaper change * Don't share towels, wash cloths, clothing, toothbrushes, or razors within the family or with friends * Discard lotions in jars (can be easily contaminated with MRSA when someone puts their hand in a jar) * Keep all wounds including cuts and scrapes clean and covered until healed * Avoid other person's dirty bandages or uncovered wounds * Encourage athletes or health club members to shower before and after all practices and competitions, and wipe down equipment surfaces before and after use * Uniforms and practice jerseys should be washed after each game or practice. Sports equipment should be washed/cleaned weekly * Wash all towels, wash cloths, sleepwear, underwear, and linens in hot water with laundry detergent once weekly and dry with hot air in a dryer | 0 | None | 0 | 5 | 0 | 5 | View |
| Hygiene Education and Decolonization | Participants in this intervention group will receive the same hygiene instructions as the participants in the first intervention group. In addition, intervention number 2 will include the following for all consented household members: Twice weekly 15 minute soaks in diluted bleach water (2/3 cup of 8.25% sodium hypochlorite \[Clorox; The Clorox Company\] for a standard 50 gallon tub of water, or a teaspoon for each 1.5 gallons of water used) for the duration of 6 weeks. Application of 2% mupirocin ointment by the use of clean swab to the bilateral anterior nares twice daily for ten days | 0 | None | 0 | 4 | 1 | 4 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nosebleed | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |