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 |
|---|---|---|---|---|---|---|---|---|
| PTOEND | PTOEND: Personally-tailored opioid overdose prevention education and naloxone distribution. Participants in this arm will be given a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment. naloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder. | 0 | None | 9 | 40 | 0 | 40 | View |
| PTOEND+PI | PTOEND+PI: Personally-tailored opioid overdose prevention education and naloxone distribution, plus Peer Intervention. In addition to a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment, participants randomized to this arm will also receive the experimental Peer Intervention. Peer Intervention: The Peer Intervention is a 20-minute telephone call delivered by a Peer Interventionist, who is trained to answer questions about the content of the personally-tailored information packets. naloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder. | 0 | None | 7 | 40 | 0 | 40 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hospitalization for musculoskeletal problem / injury | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Suicide Attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Hospitalization for nervous system disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Hospitalization related to pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
| Hospitalization for psychiatric problem | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Hospitalization for respiratory condition | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Congenital Anomaly or Birth Defect | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
| Hospitalization for renal disorder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Hospitalization for infection/abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hospitalization for multiple causes | SYSTEMATIC_ASSESSMENT | General disorders | None | View |