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 @ 5:47 PM
Ignite Modification Date: 2025-12-25 @ 3:14 PM
NCT ID: NCT01499368
Description: None
Frequency Threshold: 0
Time Frame: 4 week, 8 week and 9 week
Study: NCT01499368
Study Brief: A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lafutidine Lafutidine 20mg/day Lafutidine 10mg bid, po None None 0 165 36 165 View
Famotidine Famotidine 40mg/day Famotidine 20mg bid, po None None 0 162 30 162 View
Omeprazole Omeprazole 20mg/day Omeprazole 20mg qd(daily), po None None 3 167 34 167 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis erosive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Breath odour SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Duodenitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations None View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tinea cruris SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Burning sensation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders None View
Sensation of foreign body SYSTEMATIC_ASSESSMENT General disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pruritus generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Periorbital haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Conjunctivitis allergic SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Non-alcoholic steatohepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Mixed incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Essential hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View