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 @ 7:19 PM
Ignite Modification Date:
2025-12-25 @ 4:58 PM
NCT ID:
NCT03858803
Description:
None
Frequency Threshold:
0
Time Frame:
1 year
Study:
NCT03858803
Study Brief:
Improving the Reproductive Health of Families
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| FM2 First, LAST Delayed - Youth | Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management. Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy. | 0 | None | 0 | 161 | 0 | 161 | View |
| FM2 and LAST Simultaneous - Youth | Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment. Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management. Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy. | 0 | None | 0 | 158 | 0 | 158 | View |
| Comparison Arm - Youth | Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service. Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management. Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy. | 0 | None | 0 | 153 | 0 | 153 | View |
| FM2 First, LAST Delayed - Parent | Parent intervention, Families Matter 2 (FM2), immediate, adolescent intervention, Living as a Safer Teen (LAST), delayed six months Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management. Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy. | 0 | None | 0 | 161 | 0 | 161 | View |
| FM2 and LAST Simultaneous - Parent | Parents participate in Families Matter 2 (FM2) and adolescents in Living as a Safer Teen (LAST) intervention immediately following the baseline assessment. Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management. Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy. | 0 | None | 0 | 160 | 0 | 160 | View |
| Comparison Arm - Parent | Comparison arm in which both parents and adolescents will be offered their respective interventions following the final assessment. Following the final assessment parents will be offered the Families Matter (FM2) intervention and youth the Living as a Safer Teen (LAST) intervention as an ethically justified service. Families Matter 2: Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management. Living as a Safer Teen: Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy. | 0 | None | 0 | 152 | 0 | 152 | View |
Serious Events(If Any):
Other Events(If Any):