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 @ 3:38 AM
Ignite Modification Date: 2025-12-26 @ 2:22 AM
NCT ID: NCT01328002
Description: None
Frequency Threshold: 5
Time Frame: Adverse Event data was collected over a 17-month period from April, 2011 to September, 2012
Study: NCT01328002
Study Brief: Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Milnacipran - Open-Label Treatment Period Maximum tolerated dose (50, 75, or 100 mg/day tablets) was determined during a four-week dose escalation period, and then continued at the maximum tolerated dose for an additional four weeks. Oral administration, twice daily dosing None None 0 116 62 116 View
Placebo - Double Blind-Treatment Dose matched placebo, oral administration, twice daily dosing None None 0 6 4 6 View
Milnacipran - Double-Blind Treatment Period Maximum tolerated dose (50, 75, or 100 mg/day tablets) was determined during the open-label phase of the study. Oral administration, twice daily dosing None None 1 14 6 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (15.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (15.0) View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (15.0) View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (15.0) View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (15.0) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (15.0) View
Noncardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (15.0) View
Anorectal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (15.0) View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (15.0) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (15.0) View
Liver function test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA (15.0) View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (15.0) View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (15.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (15.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (15.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (15.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (15.0) View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (15.0) View
Blepharospasm SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (15.0) View
Blood pressure diastolic increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (15.0) View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (15.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (15.0) View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (15.0) View