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 @ 4:58 AM
Ignite Modification Date: 2025-12-26 @ 3:58 AM
NCT ID: NCT01050218
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01050218
Study Brief: Study Evaluating the Long-Term Safety of Desvenlafaxine Succinate Sustained-Release (DVS SR) in Subjects With Pain Associated With 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
DVS SR Open Label Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level. None None 26 237 199 237 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Malignant melanoma in situ NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Iron deficiency anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Diastolic dysfunction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Erosive oesophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Localised infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood glucose fluctuation NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blood glucose increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blood pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diabetes mellitus inadequate control NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Spondylolisthesis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Haemorrhage intracranial NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Status epilepticus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mental status changes NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal failure acute NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Ovarian mass NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hiccups NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary hypertension NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Iliac artery stenosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Psychiatric disorders general NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Renal and urinary disorders general NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Ear and labyrinth disorders general NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Eye disorders general NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Injury, poisoning and procedural complications general NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Investigations general NON_SYSTEMATIC_ASSESSMENT Investigations None View
Metabolism and nutrition disorders general NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Reproductive system and breast disorders general NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Respiratory, thoracic and mediastinal disorders general NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Skin and subcutaneous tissue disorders general NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View