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 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
NCT ID:
NCT00235833
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00235833
Study Brief:
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 Eow | Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan. | None | None | 10 | 25 | 25 | 25 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lymphadenitis | None | Blood and lymphatic system disorders | None | View |
| Brugada syndrome | None | Cardiac disorders | None | View |
| Pyelonephritis | None | Infections and infestations | None | View |
| Pyrexia | None | General disorders | None | View |
| Sepsis | None | Infections and infestations | None | View |
| Tendon rupture | None | Injury, poisoning and procedural complications | None | View |
| C-reactive protein increased | None | Investigations | None | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | None | View |
| Rheumatoid arthritis | None | Musculoskeletal and connective tissue disorders | None | View |
| Metastases to lymph nodes | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Non-Hodgkin's Lymphoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Ovarian neoplasm | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Rectal cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Calculus ureteric | None | Renal and urinary disorders | None | View |
| Upper respiratory tract inflammation | None | Respiratory, thoracic and mediastinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | None | Gastrointestinal disorders | None | View |
| Dental caries | None | Gastrointestinal disorders | None | View |
| Gastritis | None | Gastrointestinal disorders | None | View |
| Vomiting | None | Gastrointestinal disorders | None | View |
| Enterocolitis | None | Gastrointestinal disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Periodontitis | None | Gastrointestinal disorders | None | View |
| Adverse drug reaction | None | General disorders | None | View |
| Chest pain | None | General disorders | None | View |
| Injection site reaction | None | General disorders | None | View |
| Hepatic function abnormal | None | Hepatobiliary disorders | None | View |
| Nasopharyngitis | None | Infections and infestations | None | View |
| Cystitis | None | Infections and infestations | None | View |
| Gastroenteritis | None | Infections and infestations | None | View |
| Bronchitis | None | Infections and infestations | None | View |
| Herpes zoster | None | Infections and infestations | None | View |
| Pharyngitis | None | Infections and infestations | None | View |
| Rhinitis | None | Infections and infestations | None | View |
| Sinusitis | None | Infections and infestations | None | View |
| Tinea blanca | None | Infections and infestations | None | View |
| Tinea pedis | None | Infections and infestations | None | View |
| Upper respiratory tract infection | None | Infections and infestations | None | View |
| Contusion | None | Injury, poisoning and procedural complications | None | View |
| Arthropod sting | None | Injury, poisoning and procedural complications | None | View |
| Animal bite | None | Injury, poisoning and procedural complications | None | View |
| Fall | None | Injury, poisoning and procedural complications | None | View |
| Wound | None | Injury, poisoning and procedural complications | None | View |
| Blood glucose increased | None | Investigations | None | View |
| DNA antibody positive | None | Investigations | None | View |
| Blood alkaline phosphatase increased | None | Investigations | None | View |
| Blood triglycerides increased | None | Investigations | None | View |
| Lymphocyte percentage decreased | None | Investigations | None | View |
| Hyperuricaemia | None | Metabolism and nutrition disorders | None | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Dizziness | None | Nervous system disorders | None | View |
| Insomnia | None | Psychiatric disorders | None | View |
| Rhinorrhoea | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Upper respiratory tract inflammation | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Nasal congestion | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Pharyngolaryngeal discomfort | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Pharyngolaryngeal pain | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Productive cough | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Pruritus | None | Skin and subcutaneous tissue disorders | None | View |
| Eczema | None | Skin and subcutaneous tissue disorders | None | View |
| Rash | None | Skin and subcutaneous tissue disorders | None | View |
| Erythema | None | Skin and subcutaneous tissue disorders | None | View |
| Haemorrhage subcutaneous | None | Skin and subcutaneous tissue disorders | None | View |
| Rash erythematous | None | Skin and subcutaneous tissue disorders | None | View |
| Urticaria | None | Skin and subcutaneous tissue disorders | None | View |
| Dermatitis contact | None | Skin and subcutaneous tissue disorders | None | View |
| Hyperkeratosis | None | Skin and subcutaneous tissue disorders | None | View |
| Hypertension | None | Vascular disorders | None | View |