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 @ 3:37 PM
Ignite Modification Date:
2025-12-25 @ 1:49 PM
NCT ID:
NCT01163292
Description:
None
Frequency Threshold:
0
Time Frame:
Week 0 to Week 52
Study:
NCT01163292
Study Brief:
Special Investigation (Follow-up Survey of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859 (NCT00870467))
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 | Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859) | None | None | 5 | 106 | 46 | 106 | View |
| Non-Adalimumab | Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859) | None | None | 3 | 114 | 36 | 114 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Pyelonephritis acute | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Large intestine carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Scar | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |
| Inguinal hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J Ver. 15.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cataract | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA/J Ver. 15.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Injection site reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Liver disorder (enzyme elevation) | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Oral herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| White blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.1 | View |
| Hyperlipidaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Upper respiratory tract inflammation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.1 | View |
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.1 | View |
| Dry eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.1 | View |
| Punctate keratitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.1 | View |
| Xerophthalmia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Chelitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Dental caries | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Gastric ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Pancreatic enlargement | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Hepatic function abnormal | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.1 | View |
| Hepatic steatosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.1 | View |
| Driug-induced liver injury | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.1 | View |
| Acute sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Bronchopneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Genital candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Pneumonia bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Bronchitis bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Ligament sprain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Excoriation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J Ver. 15.1 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.1 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.1 | View |
| Liver function test abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.1 | View |
| Diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Hypercholesterolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Bursitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Osteoporosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Periarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Trigger finger | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.1 | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.1 | View |
| Breast discomfort | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 15.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Interstitial lung disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Pleural fibrosis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Pleurisy | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Pharyngeal erythema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |
| Dermatitis contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |
| Rash generalized | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |
| Seborrheic dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |