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:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:15 AM
NCT ID:
NCT01209234
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse events were actively assessed from January 2011-January 2015. Participants were recruited from January 2011-January 2014 and were followed for 1 year. Evaluation of the full text medical record reviews for adverse events occurred for several years after recruitment ended in 2014.
Study:
NCT01209234
Study Brief:
Project CLEAR - Changing Lives by Eradicating Antibiotic Resistance
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Education Arm | Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided. Standard-of-Care Education: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. | 0 | None | 0 | 1063 | 0 | 1063 | View |
| MRSA Decolonization | Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month. MRSA Decolonization: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month. | 0 | None | 0 | 1058 | 48 | 1058 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nasal Mupirocin (2%) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Nasal Mupirocin (2%) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nasal Mupirocin (2%) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nasal Mupirocin (2%) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nasal Mupirocin (2%) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nasal Mupirocin (2%) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nasal Mupirocin (2%) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Chlorhexidine Mouthwash (0.12%) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Chlorhexidine Mouthwash (0.12%) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Chlorhexidine Mouthwash (0.12%) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Chlorhexidine Mouthwash (0.12%) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Chlorhexidine Mouthwash (0.12%) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Chlorhexidine Mouthwash (0.12%) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Chlorhexidine Bodywash (4%) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Chlorhexidine Bodywash (4%) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Chlorhexidine Bodywash (4%) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Chlorhexidine Bodywash (4%) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Chlorhexidine Bodywash (4%) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Chlorhexidine Bodywash (4%) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Chlorhexidine Bodywash (4%) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Chlorhexidine Bodywash (4%) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Chlorhexidine Bodywash (4%) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Chlorhexidine Bodywash (4%) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Chlorhexidine Bodywash (4%) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Chlorhexidine Bodywash (4%) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Chlorhexidine Bodywash (4%) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Chlorhexidine Bodywash (4%) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Chlorhexidine Bodywash (4%) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Chlorhexidine Bodywash (4%) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |