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 @ 4:59 PM
Ignite Modification Date:
2025-12-25 @ 2:40 PM
NCT ID:
NCT02115750
Description:
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
Frequency Threshold:
1
Time Frame:
In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Study:
NCT02115750
Study Brief:
Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With 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 |
|---|---|---|---|---|---|---|---|---|
| Enbrel-CHS-0214 (Etanercept) | Enbrel 50mg weekly times 24 weeks and CHS-0214 for weeks 25 to 48. Etanercept: Head-to-head comparison | None | None | 27 | 320 | 245 | 320 | View |
| CHS-0214-CHS-0214 | CHS-0214 50mg weekly times 48 weeks. CHS-0214 | None | None | 20 | 604 | 241 | 604 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pneumocystis Jirovecii Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Wound Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Abscess Limb | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pilonidal Cyst | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Acute Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Angina Unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Ventricular Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cervix Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Invasive Ductal Breast Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Benign Ovarian Tumor | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Bladder Neoplasma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Breast Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Pancreatic Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Papillary Thyroid Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Peripheral Nerve Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Wound Dehiscence | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Facial Bones Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Wrist Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Rheumatoid Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Myocardial Ischemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Bronchospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Alveolitis Allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Chronic Obstructive Pulmonary Disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Gastrointestinal Motility Disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Blood Creatine Phosphokinase Increase | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Endometrial Hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Cerebrovascular Accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Ischemic Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Age-Related Macular Degeneration | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Diabetic Ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Nephrotic Syndrome | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Skin Ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Respiratory Tract Infection - Viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Herpes Zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Oral Herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Rheumatoid Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Aspartate Aminotransferase Increase | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Injury, poisoning and procedural complications | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| injection Site Reaction | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |