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 |
|---|---|---|---|---|---|---|---|---|
| Tailored Texting | Participants in this condition will chose the frequency and time of text messages that will continue until childbirth or the participant opts out. The text messages will be a mix of marijuana targeted content (without directly referring to marijuana in a way that implies use by the participant) and general content related to healthy pregnancy; using appropriate humor and tips for community resources. Tailoring will focus on gestational age, self-efficacy, and social support. Tailored texting: Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them. | 0 | None | 0 | 15 | 0 | 15 | View |
| eSBIRT & Texting | Participants in this arm will receive both the computerized intervention and tailored text messaging intervention as described in the eSBIRT and Tailored texting arms. eSBIRT: A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant. Tailored texting: Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them. | 0 | None | 0 | 15 | 0 | 15 | View |
| Electronic SBIRT (eSBIRT) | Participants in this condition will receive empathic exploration of their thoughts regarding marijuana use, provision of information on possible consequences of marijuana use during pregnancy and potential benefits of changing use (with permission), normed feedback, use of Motivational Interviewing techniques to elicit their own reasons for change, video testimonials modeling successful change, and information on change methods with optional goal setting. eSBIRT: A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant. | 0 | None | 0 | 15 | 0 | 15 | View |
| Assessment Only | Participants in the arm will participant in screening and the baseline assessment conducted on the computer only. They will not receive an intervention. | 0 | None | 0 | 8 | 0 | 8 | View |
| Screening Only | Participants in this arm of the study will only answer the screening questions and will not be asked the baseline assessment or participate in an intervention. | 0 | None | 0 | 7 | 0 | 7 | View |