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 @ 3:08 AM
Ignite Modification Date: 2025-12-26 @ 1:47 AM
NCT ID: NCT01254305
Description: The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
Frequency Threshold: 5
Time Frame: Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
Study: NCT01254305
Study Brief: Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Adults With Fatigue Associated With Major Depressive Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Matching placebo capsules, oral administration Placebo : Matching placebo capsules, oral administration, once daily dosing None None 0 89 39 89 View
Levomilnacipran ER 40 -120 mg Levomilnacipran ER capsules, oral administration, once daily for 8 weeks None None 1 85 41 85 View
SSRI Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine. Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks. None None 0 77 37 77 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Heart rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Initial insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View