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:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2025-12-26 @ 10:37 AM
NCT ID:
NCT00691028
Description:
None
Frequency Threshold:
2
Time Frame:
54 weeks
Study:
NCT00691028
Study Brief:
Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients 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 |
|---|---|---|---|---|---|---|---|---|
| TA-650 3 mg/kg (Double-blind) | 99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14. | None | None | 7 | 99 | 93 | 99 | View |
| TA-650 6 mg/kg (Double-blind) | 104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14. | None | None | 5 | 104 | 93 | 104 | View |
| TA-650 10 mg/kg (Double-blind) | 104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14. | None | None | 9 | 104 | 96 | 104 | View |
| Open-label | 327 patients received TA-650 at 3 mg/kg treatment during the open-label period. | None | None | 17 | 327 | 153 | 327 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Rheumatoid arthritis | None | Musculoskeletal and connective tissue disorders | 10.0 | View |
| Thyroid cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 10.0 | View |
| Loss of consciousness | None | Nervous system disorders | 10.0 | View |
| Gastrointestinal haemorrhage | None | Gastrointestinal disorders | 10.0 | View |
| Enterocolitis | None | Gastrointestinal disorders | 10.0 | View |
| Gastric ulcer perforation | None | Gastrointestinal disorders | 10.0 | View |
| Inguinal hernia | None | Gastrointestinal disorders | 10.0 | View |
| Mallory-Weiss syndrome | None | Gastrointestinal disorders | 10.0 | View |
| Pancreatitis acute | None | Gastrointestinal disorders | 10.0 | View |
| Peritonitis | None | Gastrointestinal disorders | 10.0 | View |
| Bile duct obstruction | None | Hepatobiliary disorders | 10.0 | View |
| Cryptococcosis | None | Infections and infestations | 10.0 | View |
| Gastroenteritis | None | Infections and infestations | 10.0 | View |
| Osteomyelitis | None | Infections and infestations | 10.0 | View |
| Pneumonia legionella | None | Infections and infestations | 10.0 | View |
| Pyelonephritis | None | Infections and infestations | 10.0 | View |
| Sepsis | None | Infections and infestations | 10.0 | View |
| Tonsillitis | None | Infections and infestations | 10.0 | View |
| Pneumonia bacterial | None | Infections and infestations | 10.0 | View |
| Anastomotic ulcer | None | Injury, poisoning and procedural complications | 10.0 | View |
| Ulna fracture | None | Injury, poisoning and procedural complications | 10.0 | View |
| Osteonecrosis | None | Musculoskeletal and connective tissue disorders | 10.0 | View |
| Bile duct cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 10.0 | View |
| Breast cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 10.0 | View |
| Tongue neoplasm malignant stage unspecified | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 10.0 | View |
| Uterine cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 10.0 | View |
| Carpal tunnel syndrome | None | Nervous system disorders | 10.0 | View |
| Interstitial lung disease | None | Respiratory, thoracic and mediastinal disorders | 10.0 | View |
| Pleural effusion | None | Respiratory, thoracic and mediastinal disorders | 10.0 | View |
| Cataract | None | Eye disorders | 10.0 | View |
| Retinal vein occlusion | None | Eye disorders | 10.0 | View |
| Gait disturbance | None | General disorders | 10.0 | View |
| Anaphylactoid reaction | None | Immune system disorders | 10.0 | View |
| Bronchiolitis | None | Infections and infestations | 10.0 | View |
| Pneumocystis jiroveci pneumonia | None | Infections and infestations | 10.0 | View |
| Hand fracture | None | Injury, poisoning and procedural complications | 10.0 | View |
| Joint dislocation | None | Injury, poisoning and procedural complications | 10.0 | View |
| Pericardial effusion | None | Cardiac disorders | 10.0 | View |
| Pericarditis | None | Cardiac disorders | 10.0 | View |
| Ascites | None | Gastrointestinal disorders | 10.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Malaise | None | General disorders | 10.0 | View |
| Pyrexia | None | General disorders | 10.0 | View |
| Hepatic function abnormal | None | Hepatobiliary disorders | 10.0 | View |
| Bronchitis | None | Infections and infestations | 10.0 | View |
| Gastroenteritis | None | Infections and infestations | 10.0 | View |
| Herpes zoster | None | Infections and infestations | 10.0 | View |
| Nasopharyngitis | None | Infections and infestations | 10.0 | View |
| Oral candidiasis | None | Infections and infestations | 10.0 | View |
| Paronychia | None | Infections and infestations | 10.0 | View |
| Pharyngitis | None | Infections and infestations | 10.0 | View |
| Pneumonia | None | Infections and infestations | 10.0 | View |
| Sinusitis | None | Infections and infestations | 10.0 | View |
| Tinea infection | None | Infections and infestations | 10.0 | View |
| Contusion | None | Injury, poisoning and procedural complications | 10.0 | View |
| Alanine aminotransferase increased | None | Investigations | 10.0 | View |
| Aspartate aminotransferase increased | None | Investigations | 10.0 | View |
| Blood pressure increased | None | Investigations | 10.0 | View |
| Gamma-glutamyltransferase increased | None | Investigations | 10.0 | View |
| Blood urine present | None | Investigations | 10.0 | View |
| Heart rate increased | None | Investigations | 10.0 | View |
| Liver function test abnormal | None | Investigations | 10.0 | View |
| White blood cell count decreased | None | Investigations | 10.0 | View |
| White blood cell count increased | None | Investigations | 10.0 | View |
| Protein urine present | None | Investigations | 10.0 | View |
| Blood alkaline phosphatase increased | None | Investigations | 10.0 | View |
| Antinuclear antibody positive | None | Investigations | 10.0 | View |
| DNA antibody positive | None | Investigations | 10.0 | View |
| Cell marker increased | None | Investigations | 10.0 | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | 10.0 | View |
| Dizziness | None | Nervous system disorders | 10.0 | View |
| Headache | None | Nervous system disorders | 10.0 | View |
| Choking sensation | None | Respiratory, thoracic and mediastinal disorders | 10.0 | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | 10.0 | View |
| Pharyngolaryngeal pain | None | Respiratory, thoracic and mediastinal disorders | 10.0 | View |
| Productive cough | None | Respiratory, thoracic and mediastinal disorders | 10.0 | View |
| Upper respiratory tract inflammation | None | Respiratory, thoracic and mediastinal disorders | 10.0 | View |
| Acne | None | Skin and subcutaneous tissue disorders | 10.0 | View |
| Dermatitis contact | None | Skin and subcutaneous tissue disorders | 10.0 | View |
| Eczema | None | Skin and subcutaneous tissue disorders | 10.0 | View |
| Heat rash | None | Skin and subcutaneous tissue disorders | 10.0 | View |
| Pruritus | None | Skin and subcutaneous tissue disorders | 10.0 | View |
| Rash | None | Skin and subcutaneous tissue disorders | 10.0 | View |
| Urticaria | None | Skin and subcutaneous tissue disorders | 10.0 | View |
| Palpitations | None | Cardiac disorders | 10.0 | View |
| Vertigo | None | Ear and labyrinth disorders | 10.0 | View |
| Conjunctivitis | None | Eye disorders | 10.0 | View |
| Abdominal pain upper | None | Gastrointestinal disorders | 10.0 | View |
| Constipation | None | Gastrointestinal disorders | 10.0 | View |
| Dental caries | None | Gastrointestinal disorders | 10.0 | View |
| Diarrhoea | None | Gastrointestinal disorders | 10.0 | View |
| Dyspepsia | None | Gastrointestinal disorders | 10.0 | View |
| Nausea | None | Gastrointestinal disorders | 10.0 | View |
| Stomach discomfort | None | Gastrointestinal disorders | 10.0 | View |
| Stomatitis | None | Gastrointestinal disorders | 10.0 | View |
| Chest discomfort | None | General disorders | 10.0 | View |
| Chest pain | None | General disorders | 10.0 | View |