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:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
NCT ID:
NCT00718718
Description:
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
Frequency Threshold:
5
Time Frame:
Screening up to Week 38
Study:
NCT00718718
Study Brief:
A Study of Effectiveness and Safety of CNTO 136 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part A - Placebo (Wk 0-Wk 12) | Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks | None | None | 0 | 19 | 12 | 19 | View |
| Part A - Placebo Then Sirukumab (Wk 12 to End of Study) | Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22. | None | None | 0 | 18 | 18 | 18 | View |
| Part A - Sirukumab (Wk 0-Wk 12) | Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. | None | None | 1 | 17 | 12 | 17 | View |
| Part A - Sirukumab Then Placebo (Wk 12 to End of Study) | Participants received placebo at Weeks 12 and q2w through Week 22. | None | None | 0 | 16 | 10 | 16 | View |
| Part B - Placebo (Wk 0-Wk 12) | Participants received placebo subcutaneously (SC) at Week 0 and q2w for 10 weeks. | None | None | 4 | 30 | 15 | 30 | View |
| Part B - Placebo Then Sirukumab 100 mg q2 Weeks | Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 24. | None | None | 2 | 26 | 11 | 26 | View |
| Part B - Sirukumab 100mg q2w | Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24. | None | None | 2 | 30 | 20 | 30 | View |
| Part B - Sirukumab 100mg q4w | Participants received 100 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22. | None | None | 5 | 30 | 18 | 30 | View |
| Part B - Sirukumab 50mg q4w | Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22. | None | None | 1 | 30 | 25 | 30 | View |
| Part B - Sirukumab 25mg q4w | Participants received 25 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22. | None | None | 3 | 31 | 23 | 31 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Blindness | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA: 13.0,13.1 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA: 13.0,13.1 | View |
| Arthritis Bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA: 13.0,13.1 | View |
| Bursitis Infective | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA: 13.0,13.1 | View |
| Cellulitis Staphylococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA: 13.0,13.1 | View |
| Pelvic Inflammatory Disease | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA: 13.0,13.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA: 13.0,13.1 | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA: 13.0,13.1 | View |
| Transaminases Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA: 13.0,13.1 | View |
| Rheumatoid Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA: 13.0,13.1 | View |
| Fibrosarcoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA: 13.0,13.1 | View |
| Facial Paresis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA: 13.0,13.1 | View |
| Intracranial Aneurysm | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA: 13.0,13.1 | View |
| Subarachnoid Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA: 13.0,13.1 | View |
| Vertebral Artery Occlusion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA: 13.0,13.1 | View |
| Uterine Polyp | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA: 13.0,13.1 | View |
| Skin Ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA: 13.0,13.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA: 13.0,13.1 | View |
| Bundle Branch Block Left | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA: 13.0,13.1 | View |
| Tinnitus | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA: 13.0,13.1 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA: 13.0,13.1 | View |
| Eye Pain | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA: 13.0,13.1 | View |
| Uveitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA: 13.0,13.1 | View |
| Vision Blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA: 13.0,13.1 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA: 13.0,13.1 | View |
| Abdominal Pain Upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA: 13.0,13.1 | View |
| Aphthous Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA: 13.0,13.1 | View |
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA: 13.0,13.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA: 13.0,13.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA: 13.0,13.1 | View |
| Periodontitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA: 13.0,13.1 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA: 13.0,13.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA: 13.0,13.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA: 13.0,13.1 | View |
| Injection Site Erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA: 13.0,13.1 | View |
| Injection Site Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA: 13.0,13.1 | View |
| Injection Site Pruritus | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA: 13.0,13.1 | View |
| Injection Site Rash | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA: 13.0,13.1 | View |
| Injection Site Swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA: 13.0,13.1 | View |
| Injection Site Urticaria | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA: 13.0,13.1 | View |
| Injection Site Warmth | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA: 13.0,13.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA: 13.0,13.1 | View |
| Hepatitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA: 13.0,13.1 | View |
| Acute Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA: 13.0,13.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA: 13.0,13.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA: 13.0,13.1 | View |
| Herpes Zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA: 13.0,13.1 | View |
| Lymphangitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA: 13.0,13.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA: 13.0,13.1 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA: 13.0,13.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA: 13.0,13.1 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA: 13.0,13.1 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA: 13.0,13.1 | View |
| Staphylococcal Skin Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA: 13.0,13.1 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA: 13.0,13.1 | View |
| Synovial Rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA: 13.0,13.1 | View |
| Alanine Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA: 13.0,13.1 | View |
| Aspartate Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA: 13.0,13.1 | View |
| Blood Bilirubin Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA: 13.0,13.1 | View |
| Blood Cholesterol Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA: 13.0,13.1 | View |
| Blood Glucose Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA: 13.0,13.1 | View |
| Blood Insulin Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA: 13.0,13.1 | View |
| Blood Potassium Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA: 13.0,13.1 | View |
| Haemoglobin Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA: 13.0,13.1 | View |
| Insulin Resistance Test | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA: 13.0,13.1 | View |
| Intraocular Pressure Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA: 13.0,13.1 | View |
| Transaminases Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA: 13.0,13.1 | View |
| White Blood Cell Count Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA: 13.0,13.1 | View |
| Hypercholesterolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA: 13.0,13.1 | View |
| Hyperlipidaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA: 13.0,13.1 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA: 13.0,13.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA: 13.0,13.1 | View |
| Intervertebral Disc Degeneration | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA: 13.0,13.1 | View |
| Musculoskeletal Chest Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA: 13.0,13.1 | View |
| Musculoskeletal Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA: 13.0,13.1 | View |
| Neck Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA: 13.0,13.1 | View |
| Pain in Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA: 13.0,13.1 | View |
| Rheumatoid Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA: 13.0,13.1 | View |
| Spinal Column Stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA: 13.0,13.1 | View |
| Tendon Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA: 13.0,13.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA: 13.0,13.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA: 13.0,13.1 | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA: 13.0,13.1 | View |
| Sciatica | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA: 13.0,13.1 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA: 13.0,13.1 | View |
| Upper Respiratory Tract Inflammation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA: 13.0,13.1 | View |
| Dry Skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA: 13.0,13.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA: 13.0,13.1 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA: 13.0,13.1 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA: 13.0,13.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA: 13.0,13.1 | View |
| Thrombophlebitis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA: 13.0,13.1 | View |
| Haemorrhagic Diathesis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA: 13.0,13.1 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA: 13.0,13.1 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA: 13.0,13.1 | View |