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 |
|---|---|---|---|---|---|---|---|---|
| A: Didactic Safer Injection and Sexual Activity Education | In each city, 75 women will participate in a 60 minute didactic presentation and printed materials on safer sex and safer injection based on CDC guidelines for HIV counseling, testing, and referral and materials from Mexico's National Center for AIDS Studies (CENSIDA). In this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection. | None | None | 5 | 144 | 0 | 144 | View |
| B: Interactive Injection Risk Intervention and Didactic Safer | In each city, 75 women will participate in the 60 minute "Di No a las Jeringas Contaminadas" \['Say No to Contaminated Syringes'\] counseling session. This one on one intervention incorporates elements of motivational interviewing (MI) and principles of SCT/TRA to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared. In addition, participants will be provided a didactic presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex. | None | None | 3 | 146 | 0 | 146 | View |
| C:Interactive Sexual Risk Intervention & Didactic Safer | In each city, 75 women will participate in the 60 minute "Di No Al Sexo Inseguro" \[Say No to Unsafe Sex'\] counseling session. This one on one intervention incorporates elements of MI and principles of SCT/TRA to address the context of unsafe sex and condom use with clients. In addition, participants will be provided a didactic presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior. | None | None | 8 | 148 | 0 | 148 | View |
| D: Interactive Injection and Sexual Risk Intervention | In each city, 75 women will participate in the 60 minute "Di No a las Jeringas Contaminadas" \['Say No to Contaminated Syringes'\] and "Di No Al Sexo Inseguro" \[Say No to Unsafe Sex'\] counseling session. This one-on-one intervention incorporates elements of MI and principles of SCT/TRA to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., HIV, STIs, pregnancy). | None | None | 4 | 146 | 0 | 146 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Participants Affected/at risk | NON_SYSTEMATIC_ASSESSMENT | Social circumstances | Serious and other | View |