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 @ 12:00 AM
Ignite Modification Date: 2025-12-25 @ 9:57 PM
NCT ID: NCT02466958
Description: None
Frequency Threshold: 0
Time Frame: 09/2016 - 07/2018; 1 years and 10 months
Study: NCT02466958
Study Brief: Trial of Levomilnacipran in Geriatric Depression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Levomilnacipran (FETZIMA) All eligible subjects will be randomized to levomilnacipran or placebo group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. levomilnacipran: antidepressant 0 None 0 17 11 17 View
Placebo All eligible subjects will be randomized to levomilnacipran or placebo group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Placebo: an inactive drug 0 None 0 12 2 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased blood pressure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Teeth grinding SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sleepiness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Decreased duration of sleep SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Reduced salivation SYSTEMATIC_ASSESSMENT General disorders None View
Sweating SYSTEMATIC_ASSESSMENT General disorders None View
Falls SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upset stomach SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Micturition disturbance SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Orthostatic dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Orgastic dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Heart palpitations/tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Visual disturbances SYSTEMATIC_ASSESSMENT General disorders None View