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 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
NCT ID:
NCT01007435
Description:
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
Frequency Threshold:
5
Time Frame:
Adverse events were reported from Baseline through Week 52.
Study:
NCT01007435
Study Brief:
A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe 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 |
|---|---|---|---|---|---|---|---|---|
| Placebo to Tocilizumab + Methotrexate | Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks. | None | None | 24 | 282 | 177 | 282 | View |
| Tocilizumab 4 mg/kg + Methotrexate | Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks. | None | None | 29 | 289 | 182 | 289 | View |
| Tocilizumab 8 mg/kg + Methotrexate | Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks. | None | None | 31 | 290 | 201 | 290 | View |
| Tocilizumab 8 mg/kg + Placebo to Methotrexate | Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks. | None | None | 25 | 292 | 163 | 292 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Bronchopneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Appendicitis perforated | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Arthritis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Lyme disease | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Pneumococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Pneumonia bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Pneumonia influenzal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Staphylococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Colon cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Endometrial cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Endometrial cancer stage I | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Hepatic neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Lung neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Metastatic bronchial carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Ovarian germ cell teratoma benign | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Renal cancer stage II | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Renal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Uterine leiomyoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Pulmonary fibrosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Acute respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Haemothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Fibula fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Intentional overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Meniscus lesion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Tendon rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Tibia fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Cerebral ischaemia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Hypoglycaemic coma | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Peroneal nerve palsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| VIth nerve paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Myocardial fibrosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Sick sinus syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Silent myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Rheumatoid arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Gouty arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Intervertebral disc protrusion osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Osteonecrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Anal fissure | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Food poisoning | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (15.0) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| Arteriosclerosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| Peripheral ischaemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| Peripheral vascular disorder | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.0) | View |
| Biliary dyskinesia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.0) | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| Diabetes mellitus inadequate control | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| Endometrial hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (15.0) | View |
| Epididymal cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (15.0) | View |
| Metrorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (15.0) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Renal cyst | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.0) | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.0) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| Neurosensory hypoacusis | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (15.0) | View |
| Anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (15.0) | View |
| Suicide attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Oteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Rheumatoid arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |