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 @ 3:01 PM
Ignite Modification Date: 2025-12-25 @ 1:24 PM
NCT ID: NCT01041859
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01041859
Study Brief: A Study to Evaluate the Efficacy, Safety, and Tolerability of Tapentadol ER Compared With Placebo in Patients With Chronic, Painful Diabetic Peripheral Neuropathy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DB Placebo Double-Blind Placebo Control Group None None 9 152 37 152 View
DB Tapentadol ER Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks None None 8 166 86 166 View
OL Tapentadol Tapentadol extended release (ER) 50 100 150 200 250 mg twice daily for 3 weeks None None 11 459 296 459 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastrointestinal Disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastrointestinal Haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Diabetic Foot Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Gastroenteritis Viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Localised Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Necrotising Fasciitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Diabetes Mellitus Inadequate Control NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Arterial Stenosis Limb NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Acute Coronary Syndrome NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Angina Unstable NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Atrial Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Coronary Artery Disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Coronary Artery Occlusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Myocardial Ischaemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Balance Disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Suicidal Ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Pleural Effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Bronchospasm NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Dry Gangrene NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.1 View
Vision Blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Skull Fractured Base NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Subdural Haematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Traumatic Brain Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Electrocardiogram Change NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Urinary Retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Coronary Arterial Stent Insertion NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 13.1 View
Coronary Artery Bypass NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View