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 @ 3:31 PM
Ignite Modification Date:
2025-12-25 @ 1:45 PM
NCT ID:
NCT03789292
Description:
Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit
Frequency Threshold:
3
Time Frame:
Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).
Study:
NCT03789292
Study Brief:
A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active 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 |
|---|---|---|---|---|---|---|---|---|
| Treatment 1: EU-approved Humira | Patients were administered EU-approved Humira (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24. | 0 | None | 19 | 324 | 118 | 324 | View |
| Treatment 1: CT-P17 | Patients were administered CT-P17 (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24. | 0 | None | 12 | 324 | 96 | 324 | View |
| Treatment 2: CT-P17 Maintenance | All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48. | 0 | None | 6 | 303 | 50 | 303 | View |
| Treatment 2: Humira Maintenance | Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48. | 0 | None | 3 | 152 | 35 | 152 | View |
| Treatment 2: Switched to CT-P17 | Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48. | 0 | None | 5 | 152 | 33 | 152 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Angina Unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Retinal vein thrombosis | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Vitreous hemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hepatic failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Nonalcoholic fatty liver disease | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Breast abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Chronic tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Epididymitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Gastroenteritis rotavirus | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Otitis media acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pulmonary tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pyelonephritis acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Extradural hematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Limb crushing injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Tendon rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Myositis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Rheumatoid arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Benign muscle neoplasm | 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 |
| Uterine leiomyoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Amyotrophic lateral sclerosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Carotid artery occlusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Ischemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Endometrial hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Endometriosis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Rheumatoid lung | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Cataract operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Polypectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Latent tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |