Adverse Events Module

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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

Ignite Creation Date: 2025-12-25 @ 3:05 AM
Ignite Modification Date: 2025-12-26 @ 1:44 AM
NCT ID: NCT03390933
Description: Participants will be seen on a weekly basis. Every other week, the study nurse practitioner will review any side effects the participant is having and record any adverse events. These check ins will be recorded on the study Progress Note and also the Fluoxetine Follow Up Checklist form. These notes will be reviewed on a weekly basis by the study team as a whole.
Frequency Threshold: 1
Time Frame: All side effects ASSESSED EVERY OTHER WEEK OVER A TWELVE WEEK PERIOD while patients were actively taking fluoxetine.
Study: NCT03390933
Study Brief: Identifying and Treating Depression in Hemodialysis Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fluoxetine Group Approximately 96 patients will be enrolled into the intervention (Phase II) over the duration of the entire study. Fluoxetine: Patients enrolled into Phase II will be prescribed 2 weeks of short-acting fluoxetine 20 mg and will be instructed to take the prescription daily for 2 weeks. Then patients will be prescribed 10 additional weeks of 90 mg (weekly) fluoxetine and will be observed taking it once weekly at the dialysis unit. At the end of the 12 week study period, participants will be provided 4 additional weeks of 90 mg fluoxetine in order to provide sufficient time to follow up with their primary care physician or nephrologist. 0 None 0 16 1 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View