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 |
|---|---|---|---|---|---|---|---|---|
| Vamousse Spray 'n' Go | 1. Recruitment Details: Upon arrival at the clinic, lice-infested patients and their household members were screened for eligibility against the inclusion and exclusion criteria. Those in each household who passed the screening were assigned to one of the two treatment groups through a reversing alternation assignment procedure. 2. Type of Units Assigned: Vamousse Spray 'n' Go Treatment Group: members of this group were treated at baseline and, if live lice were found, again at Day 7 subsequent to baseline with the Vamousse Spray 'n' Go product, which is a pediculicide for topical application, having as its active ingredient Natrum Muriaticum 2X (HPUS). 3. Periods: A. Baseline to Day 7 Assessment 1) Completed 41 of the 43 subjects in this group completed this period. 2) Not Completed 2 subjects in this group dropped out of the study prior to the Day 7 assessment. B. Baseline to Day 14 Assessment 1) Completed 41 of the original 43 subjects in this group completed this period. 2) Not Completed 2 subjects in this group dropped out of the study prior to the 14th day after baseline. 4. Reasons Not Completed A. Reason Not Completed Type 1) Subject #16: Withdrawal by subject 2) Subject #17: Withdrawal by subject B. Reason Not Completed Data Withdrawal by subject: N = 2 | 0 | None | 0 | 43 | 0 | 43 | View |
| Nix Creme Rinse Lice Treatment | 1. Recruitment Details: Upon arrival at the clinic, lice-infested patients and their household members were screened for eligibility against the inclusion and exclusion criteria. Those in each household who passed the screening were assigned to one of the two treatment groups through a reversing alternation assignment procedure. 2. Type of Units Assigned: Nix Creme Rinse Lice Treatment Group: members of this group were treated at baseline and, if live lice were found, again at Day 7 subsequent to baseline with the Nix Creme Rinse Lice Treatment product, which is a pediculicide topical application having as its active ingredient permethrin at 1% concentration. 3. Periods: A. Baseline to Day 7 Assessment 1) Completed 15 of the 15 subjects in this group completed this period. 2) Not Completed No subjects in this group dropped out of the study prior to the Day 7 assessment. B. Baseline to Day 14 Assessment 1) Completed 15 of the original 15 subjects in this group completed this period. 2) Not Completed No subjects in this group dropped out of the study prior to the 14th day after baseline. 4. Reasons Not Completed No subjects in this treatment group failed to complete the study. | 0 | None | 0 | 15 | 0 | 15 | View |