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 @ 7:30 PM
Ignite Modification Date: 2025-12-25 @ 5:11 PM
NCT ID: NCT00516503
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00516503
Study Brief: Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Baclofen-amitriptyline Hydrochloride-ketamine Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically. None None 1 101 48 101 View
Placebo Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically None None 1 102 45 102 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 10 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Ileal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 10 View
Bladder infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Syncope vasovagal SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Hand-and-foot syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View