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 @ 12:22 AM
Ignite Modification Date: 2025-12-25 @ 10:26 PM
NCT ID: NCT02355158
Description: An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Frequency Threshold: 5
Time Frame: 1 year 7 days
Study: NCT02355158
Study Brief: A Safety Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Painful Diabetic 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
Active Clonidine hydrochloride topical gel, 0.1% clonidine hydrochloride topical gel, 0.1% 1 None 23 197 79 197 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (13.1) View
Myodcaridal infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (13.1) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (13.1) View
Coronary artery occlusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (13.1) View
Tachyarrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (13.1) View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View
Staphylococcal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.1) View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.1) View
Costochondritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (13.1) View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (13.1) View
Chronic lymphocytic leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (13.1) View
Skin cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (13.1) View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (13.1) View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (13.1) View
Obesity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (13.1) View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (13.1) View
Ischaemic limb pain SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (13.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 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
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (13.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.1) View