Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 3:18 AM
Ignite Modification Date: 2025-12-26 @ 1:57 AM
NCT ID: NCT00796705
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00796705
Study Brief: Switching Anti-TNF-Alpha Agents in Rheumatoid Arthritis (RA)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Non-Switcher/Adalimumab Subjects failing Adalimumab at screening who were randomized to remain on Adalimumab None None 0 3 3 3 View
Non-Switcher/Etanercept Subjects failing Etanercept at screening who were randomized to remain on Etanercept None None 0 4 3 4 View
Switcher/Adalimumab to Etanercept Subjects failing Adalimumab at screening who were randomized to switch to Etanercept None None 0 4 4 4 View
Switcher/Etanercept to Adalimumab Subjects failing Etanercept at screening who were randomized to switch to Adalimumab None None 0 2 2 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal 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
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection site irritation SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Excoriation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Cardiac murmur SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Gallop rhythm present SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Rheumatoid arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Prolonged expiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Tonsillar hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View