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 @ 1:24 AM
Ignite Modification Date: 2025-12-25 @ 11:34 PM
NCT ID: NCT00603993
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00603993
Study Brief: Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Adalimumab 40 mg or 80 mg Every Other Week (Eow) Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 \[NCT00235872\]) subcutaneously (sc) eow until approval of adalimumab in Japan None None 20 88 84 88 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina pectoris None Cardiac disorders None View
Atrial thrombosis None Cardiac disorders None View
Cardiac failure None Cardiac disorders None View
Vertigo positional None Ear and labyrinth disorders None View
Cataract None Eye disorders None View
Enterocolitis None Gastrointestinal disorders None View
Ileus None Gastrointestinal disorders None View
Cellulitis None Infections and infestations None View
Enteritis infectious None Infections and infestations None View
Herpes zoster None Infections and infestations None View
Urinary tract infection None Infections and infestations None View
Clavicle fracture None Injury, poisoning and procedural complications None View
Joint dislocation None Injury, poisoning and procedural complications None View
Ligament rupture None Injury, poisoning and procedural complications None View
Tendon rupture None Injury, poisoning and procedural complications None View
Joint destruction None Musculoskeletal and connective tissue disorders None View
Knee deformity None Musculoskeletal and connective tissue disorders None View
Rheumatoid arthritis None Musculoskeletal and connective tissue disorders None View
Malignant ascites None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Ovarian cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Renal failure acute None Renal and urinary disorders None View
Asthma None Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia None Blood and lymphatic system disorders None View
Vertigo None Ear and labyrinth disorders None View
Constipation None Gastrointestinal disorders None View
Dental caries None Gastrointestinal disorders None View
Diarrhoea None Gastrointestinal disorders None View
Abdominal pain upper None Gastrointestinal disorders None View
Gingivitis None Gastrointestinal disorders None View
Haemorrhoids None Gastrointestinal disorders None View
Stomatitis None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Adverse drug reaction None General disorders None View
Hepatic function abnormal None Hepatobiliary disorders None View
Seasonal allergy None Immune system disorders None View
Nasopharyngitis None Infections and infestations None View
Bronchitis None Infections and infestations None View
Upper respiratory tract infection None Infections and infestations None View
Pharyngitis None Infections and infestations None View
Tinea infection None Infections and infestations None View
Contusion None Injury, poisoning and procedural complications None View
Fall None Injury, poisoning and procedural complications None View
Antinuclear antibody positive None Investigations None View
DNA antibody positive None Investigations None View
Protein urine present None Investigations None View
Back pain None Musculoskeletal and connective tissue disorders None View
Rheumatoid arthritis None Musculoskeletal and connective tissue disorders None View
Headache None Nervous system disorders None View
Insomnia None Psychiatric disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Upper respiratory tract inflammation None Respiratory, thoracic and mediastinal disorders None View
Rhinorrhoea None Respiratory, thoracic and mediastinal disorders None View
Pharyngolaryngeal pain None Respiratory, thoracic and mediastinal disorders None View
Pharyngolaryngeal discomfort None Respiratory, thoracic and mediastinal disorders None View
Pruritus None Skin and subcutaneous tissue disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Eczema None Skin and subcutaneous tissue disorders None View
Erythema None Skin and subcutaneous tissue disorders None View
Hyperkeratosis None Skin and subcutaneous tissue disorders None View