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 @ 1:05 AM
Ignite Modification Date: 2025-12-25 @ 11:18 PM
NCT ID: NCT00408993
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00408993
Study Brief: Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China
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 Placebo None None 2 None 77 None View
Duloxetine 60/120 mg QD Duloxetine 60/120 mg QD None None 2 None 85 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Stomach discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Therapeutic response unexpected SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View