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 |
|---|---|---|---|---|---|---|---|---|
| Uni-directional SMS | Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages. Uni-directional SMS: Exposure to breastfeeding promoting SMSs Feature phone: Participants were given a feature phone. | None | None | 0 | 20 | 0 | 20 | View |
| Virtual Communities | Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology. Uni-directional SMS: Exposure to breastfeeding promoting SMSs Feature phone: Participants were given a feature phone. Virtual communities: Exposure to virtual community communication via SMS | None | None | 0 | 24 | 0 | 24 | View |
| Hybrid Setup | Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community. Uni-directional SMS: Exposure to breastfeeding promoting SMSs Feature phone: Participants were given a feature phone. Virtual communities: Exposure to virtual community communication via SMS Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS | None | None | 0 | 22 | 0 | 22 | View |
| Control Group | Individuals were given a feature phone (simple mobile phone) Feature phone: Participants were given a feature phone. | None | None | 0 | 12 | 0 | 12 | View |