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: NCT00844194
Description: 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.
Frequency Threshold: 5
Time Frame: 14 weeks
Study: NCT00844194
Study Brief: Duloxetine in Patients With Diabetic in Peripheral Neuropathic Pain With or Without Co-morbid 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
Without Major Depressive Disorder (MDD-) Patients with diabetic polyneuropathy and no depression None None 4 78 28 78 View
With Major Depressive Disorder (MDD+) Patients with diabetic polyneuropathy and depression None None 2 30 16 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Meningioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meddra 13.1 View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders Meddra 13.1 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders Meddra 13.1 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders Meddra 13.1 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders Meddra 13.1 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders Meddra 13.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders Meddra 13.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Meddra 13.1 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Meddra 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Meddra 13.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Meddra 13.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Meddra 13.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Meddra 13.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders Meddra 13.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders Meddra 13.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Meddra 13.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Meddra 13.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders Meddra 13.1 View
Micturition disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders Meddra 13.1 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders Meddra 13.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 13.1 View