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 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
NCT ID:
NCT02934620
Description:
The number of participants at risk for all the adverse event terms are less than the \*\*Total\*\* number of participants at risk for other adverse events in both arms. This is due to missing data for some survey items. If the survey item did not have a response recorded, we did not include the participant in the number at risk.
Other (Not Including Serious) Adverse Events were not monitored/assessed For "Male Partners" Arm/Groups.
Frequency Threshold:
5
Time Frame:
6 months
Study:
NCT02934620
Study Brief:
Promoting CSD500 Use Among Women in Established Relationships
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| CSD500 Condom - Female Participants | Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure. | 0 | None | 0 | 248 | 68 | 240 | View |
| Standard Condom - Female Participants | Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure. | 0 | None | 0 | 252 | 2 | 240 | View |
| CSD500 Condom - Male Participants | Receive CSD500 condoms with condom counseling to use them for sexual pleasure. CSD500 Condom: CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure. | 0 | None | 0 | 248 | 0 | 0 | View |
| Standard Condom -Male Participants | Receive the standard condom with condom counseling to use them for pregnancy and disease prevention. Standard Condom: The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention. Condom Counseling: The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure. | 0 | None | 0 | 252 | 0 | 0 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headaches at 2-month among Female Participants | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Headaches at 4-month among Female Participants | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Headaches at 6-month among Female Participants | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dizziness at 2 months among Female Participants | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dizziness at 4 months among Female Participants | SYSTEMATIC_ASSESSMENT | General disorders | None | View |