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 @ 2:15 PM
Ignite Modification Date:
2025-12-25 @ 12:53 PM
NCT ID:
NCT02557295
Description:
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
Frequency Threshold:
3
Time Frame:
Duration of study participation (up to 5 years)
Study:
NCT02557295
Study Brief:
An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With 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 |
|---|---|---|---|---|---|---|---|---|
| Remsima | Patients who have received only Remsima or switched from non-biologic treatment to Remsima were included in this analysis group. | 0 | None | 16 | 111 | 56 | 111 | View |
| Switch to Remsima I | Patients who switched from Remicade to Remsima were included in this analysis group. | 0 | None | 2 | 8 | 6 | 8 | View |
| Switch to Remsima II | Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group. | 0 | None | 4 | 15 | 7 | 15 | View |
| Remicade | Patients who have received only Remicade or switched from non-biologic treatment to Remicade were included in this analysis group. | 0 | None | 2 | 3 | 3 | 3 | View |
| Switch to Remicade I | Patients who switched from Remsima to Remicade were included in this analysis group. | 0 | None | 0 | 0 | 0 | 0 | View |
| Switch to Remicade II | Patients who switched to Remicade from biologic treatment other than Remsima will be included in this analysis group. | 0 | None | 0 | 0 | 0 | 0 | View |
| Other Anti-TNF | Following patients were included in other anti-TNF group. * Patients who have received only anti-TNF other than Remsima or Remicade * Patients who switched from non-biologic treatment to anti-TNF other than Remsima or Remicade * Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade | 0 | None | 11 | 81 | 39 | 81 | View |
| Switch to Other Anti-TNF | Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade will be included in this analysis group. | 0 | None | 0 | 7 | 3 | 7 | View |
| Biologic Naïve | Patients who received only non-biologic treatment will be included in this analysis group. | 0 | None | 2 | 23 | 13 | 23 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Prinzmetal angina | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Enterocolitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Epigastric discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Arthritis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Otitis Media | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pyelonephritis acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Cervical vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Facial Bones Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Intentional overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Meniscus injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Patella fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hepatic Enzyme Increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Lumbar Spinal Stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Renal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Adenomyosis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Ovarian cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Urticarial vasculitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Intraductal proliferative breast lesion | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gastric polyps | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Oesophageal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hepatic Cyst | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hepatitis Acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Fungal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Latent Tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Tinea Pedis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Vaginal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Tooth Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hepatic Enzyme Increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hypophagia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Osteoporosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Rheumatoid Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Spinal Column Stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Lactation Disorder | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Chronic Obstructive Pulmonary Disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Dermatitis Contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Swelling face | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hepatic steatosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Localized Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Otitis externa | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pyelonephritis acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Liver function test increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hyperlipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Scleroderma | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Benign neoplasm of thyroid gland | 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 |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Hypertonic bladder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Menopausal disorder | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Dydspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |