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:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
NCT ID:
NCT03673956
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse events were collected from baseline to end of study for a total of approximately 2 months on all participants.
Study:
NCT03673956
Study Brief:
Topical Antibiotics in Chronic Rhinosinusitis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Mupirocin Antibiotic Nasal Saline Rinse | Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Mupirocin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy. Mupirocin: 30mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days. | 0 | None | 0 | 12 | 0 | 12 | View |
| Tobramycin Topical Antibiotic Nasal Saline Rinse | Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Tobramycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy. Tobramycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days. | 0 | None | 0 | 1 | 1 | 1 | View |
| Levofloxacin Topical Antibiotic Nasal Saline Rinse | Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Levofloxacin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy. Levofloxacin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days. | 0 | None | 0 | 5 | 1 | 5 | View |
| Vancomycin Topical Antibiotic Nasal Saline Rinse | Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Vancomycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy. Vancomycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days. | 0 | None | 0 | 1 | 0 | 1 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Face Pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Facial Pressure | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nasal Drainage | SYSTEMATIC_ASSESSMENT | General disorders | None | View |