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 |
|---|---|---|---|---|---|---|---|---|
| 6 IPT-A Sessions | IPT Only Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. | 0 | None | 0 | 8 | 0 | 8 | View |
| 6 IPT-A Sessions + Continue Current Dose of Fluoxetine | IPT with continued current fluoxetine dosage Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. | 0 | None | 0 | 3 | 0 | 3 | View |
| 10 IPT-A Sessions + Begin Fluoxetine | IPT with new fluoxetine use Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. | 0 | None | 0 | 2 | 0 | 2 | View |
| 10 IPT-A Sessions + Increase Dose of Fluoxetine | IPT with increased dose of fluoxetine Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. | 0 | None | 0 | 1 | 0 | 1 | View |