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 |
|---|---|---|---|---|---|---|---|---|
| Patients With Depression: CBT and SPECT | Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with cognitive behavioral therapy. Cognitive behavioral therapy (CBT): Participants will attend twice weekly CBT sessions for 2 weeks and then once weekly sessions for 10 weeks. Sessions will focus on modifying thoughts and behaviors that may contribute to depression. TRODAT-1 single photon emission computed tomographic (SPECT) imaging: Participants' striatal dopamine transporter (DAT) levels will be measured using \[99mTc\]TRODAT-1 SPECT with magnetic resonance imaging (MRI) co-localization on two separate occasions. Participants with depression will undergo TRODAT-1 SPECT imaging immediately before and after 12 weeks of their assigned treatment. Healthy participants will undergo TRODAT-1 SPECT imaging at baseline and 12 weeks later. | 0 | None | 0 | 0 | 0 | 0 | View |
| Patients With Depression Without CBT | Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with s-citalopram. S-citalopram: Participants will take 10 to 30 mg of s-citalopram daily for 12 weeks. TRODAT-1 single photon emission computed tomographic (SPECT) imaging: Participants' striatal dopamine transporter (DAT) levels will be measured using \[99mTc\]TRODAT-1 SPECT with magnetic resonance imaging (MRI) co-localization on two separate occasions. Participants with depression will undergo TRODAT-1 SPECT imaging immediately before and after 12 weeks of their assigned treatment. Healthy participants will undergo TRODAT-1 SPECT imaging at baseline and 12 weeks later. | 0 | None | 0 | 0 | 0 | 0 | View |
| Healthy Participants | Healthy participants will undergo TRODAT-1 SPECT imaging. TRODAT-1 single photon emission computed tomographic (SPECT) imaging: Participants' striatal dopamine transporter (DAT) levels will be measured using \[99mTc\]TRODAT-1 SPECT with magnetic resonance imaging (MRI) co-localization on two separate occasions. Participants with depression will undergo TRODAT-1 SPECT imaging immediately before and after 12 weeks of their assigned treatment. Healthy participants will undergo TRODAT-1 SPECT imaging at baseline and 12 weeks later. | 0 | None | 0 | 0 | 0 | 0 | View |