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 @ 1:46 AM
Ignite Modification Date: 2025-12-26 @ 12:05 AM
NCT ID: NCT05323994
Description: None
Frequency Threshold: 1
Time Frame: 8 weeks
Study: NCT05323994
Study Brief: Effectiveness and Tolerability of аgomelatine in the Treatment of Patients With Depression After SARS-CoV-2 (TELESPHOR)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Patients With Depression Occurred After COVID 19 Patients with the major depressive disorder (total score 8-24 on HAMD-17 - The Hamilton Rating Scale for Depression (HRSD), also called the Hamilton Depression Rating Scale (HDRS), sometimes also abbreviated as HAM-D, is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. It consists of 20 questions. For assessment of the severity of condition using a summary of total score where 0 - 7 "normal", 8 - 15 "mild depression",16 - 24 "moderate depression", 25 and more "severe depression" Depression treatment by agomelatine according to SMPC (Summary of Product Characteristics) 0 None 0 103 1 103 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
inefficiency of treatment NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v.25.1. View