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 @ 3:27 AM
Ignite Modification Date: 2025-12-26 @ 2:08 AM
NCT ID: NCT04198805
Description: None
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT04198805
Study Brief: Vitamin E and DHA-EE on NAFLD - Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial (PUVENAFLD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vitamin E (1000 mg) Vitamin E (1000 mg) once daily for 6 months (1 capsule) and matching placebos (2 matched capsules) for 6 months. Vitamin E \[(all-rac)-α-tocopheryl acetate\]: Vitamin E (1000 mg) once daily for 6 months (1 capsule) and matching placebos (2 matched capsules) for 6 months 0 None 0 34 6 34 View
DHA EE (1.89 g) DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months). Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months) 0 None 0 34 17 34 View
DHA EE (1.89 g) and Vitamin E (1000 mg) DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months. Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months 0 None 1 67 18 67 View
Placebo Matching soybean oil placebo (3 capsules) of all arms daily for 6 months. Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months. 1 None 1 70 25 70 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anxiety SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypertonic Bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Meniscus injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bell's Palsy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Diverticulum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cholelithiasis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Food poisioning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chronic gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Eosinophilic esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Esophageal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Edema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diabetes mellitus type 2 SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Migraine SYSTEMATIC_ASSESSMENT General disorders None View
Deafness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Liver function test increased SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mastoiditis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Foreign body in eye SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Rheumatoid arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Remnant hyperlipidemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blood glucose increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fibromyalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chalazion SYSTEMATIC_ASSESSMENT Eye disorders None View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Vascular disorders None View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Neoplasm skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Desmoid tumor SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Endometriosis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hepatitis C SYSTEMATIC_ASSESSMENT Infections and infestations None View
Heavy menstrual bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View