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: 2025-12-24 @ 11:38 PM
Ignite Modification Date: 2025-12-25 @ 9:28 PM
NCT ID: NCT00618956
Description: For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
Frequency Threshold: 5
Time Frame: 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
Study: NCT00618956
Study Brief: A Study Of Milnacipran In Patients With Fibromyalgia: Effects On 24 Hour Ambulatory Blood Pressure Monitoring
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 ITT N= 93, OC analyzed n=89 None None 1 111 42 111 View
Milnacipran Milnacipran 100 to 200 mg/day tablet, oral administration, BID. None None 6 210 117 210 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Uterine Haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Complicated Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Coronary Artery Stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Multiple Injuries SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Periorbital Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Peritoneal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Wrist Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Hypertensive Crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Hiatus Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Pericardial Effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Rib Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Spelnic Rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Hot Flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Fibromyalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View