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 @ 1:33 AM
Ignite Modification Date: 2025-12-25 @ 11:46 PM
NCT ID: NCT01377194
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 was collected over a 10 month period from June 2011 to March 2012.
Study: NCT01377194
Study Brief: Safety and Efficacy of Levomilnacipran ER (Levomilnacipran SR) in 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
Levomilnacipran ER 40 mg 40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks. None None 3 188 90 188 View
Placebo Dose matched placebo, oral administration in capsule form, once daily for 8 weeks. None None 1 186 58 186 View
Levomilnacipran 80 mg 40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks. None None 0 188 110 188 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Facial Bones Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.1 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Intussusception SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal 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
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Urinary hesitation SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.1 View
Heart rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.1 View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 14.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Testicular pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 14.1 View