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 @ 12:47 PM
Ignite Modification Date:
2025-12-25 @ 12:15 PM
NCT ID:
NCT01606761
Description:
For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
Frequency Threshold:
5
Time Frame:
Up to Week 68
Study:
NCT01606761
Study Brief:
A Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy (SIRROUND-T)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| W24 to W52-Placebo to 50 mg q4w Due to EE or CO | Participants who received matching placebo in the placebo controlled period and were re-randomized (due to early escape \[EE\] at Week 18 or crossed over \[CO\] at Week 24) to receive subcutaneous (SC) sirukumab 50 mg q4w dose regimen up to Week 52. | None | None | 8 | 124 | 50 | 124 | View |
| W24 to W52-Placebo to 100 mg q2w Due to EE or CO | Participants who received matching placebo in the placebo controlled period and were re-randomized (due to early escape \[EE\] at Week 18 or crossed over \[CO\] at Week 24) to receive subcutaneous (SC) sirukumab 100 mg q4w dose regimen up to Week 52. | None | None | 18 | 126 | 63 | 126 | View |
| W52-Sirukumab 100 mg q2w | Participants received sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 52. | None | None | 37 | 292 | 169 | 292 | View |
| W52 to W68-Placebo | Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68. | None | None | 0 | 28 | 0 | 28 | View |
| W52 to W68-Placebo to 50 mg q4w Due to EE or CO | Participants who discontinued or completed sirukumab 50 mg q4w due to EE or CO administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68. | None | None | 0 | 7 | 1 | 7 | View |
| W52 to W68-Sirukumab 50 mg q4w | Participants who discontinued or completed sirukumab 50 mg q4w administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68. | None | None | 1 | 65 | 2 | 65 | View |
| W52 to W68-Sirukumab 100 mg q2w | Participants who discontinued or completed sirukumab 100 mg q2w administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68. | None | None | 0 | 62 | 4 | 62 | View |
| Week (W) 24-Placebo | Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossover (CO) at Week 24. | None | None | 15 | 294 | 106 | 294 | View |
| W52-Sirukumab 50 mg q4w | Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52. | None | None | 51 | 292 | 152 | 292 | View |
| W52 to W68-Placebo to 100 mg q2w Due to EE or CO | Participants who discontinued or completed sirukumab 100 mg q2w due to EE or CO administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68. | None | None | 2 | 19 | 3 | 19 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Periprosthetic Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 17.0 | View |
| Tendon Rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 17.0 | View |
| Aspartate Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 17.0 | View |
| Hepatic Enzyme Abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 17.0 | View |
| Hepatic Enzyme Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 17.0 | View |
| Liver Function Test Abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 17.0 | View |
| Morganella Test Positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 17.0 | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 17.0 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 17.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | View |
| Arthropathy | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | View |
| Foot Deformity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | View |
| Haemarthrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | View |
| Intervertebral Disc Protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | View |
| Musculoskeletal Chest Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | View |
| Osteochondrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | View |
| Osteonecrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | View |
| Rheumatoid Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | View |
| Soft Tissue Necrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | View |
| Spondylolisthesis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | View |
| Breast Cancer Metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 17.0 | View |
| Chondroma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 17.0 | View |
| Invasive Ductal Breast Carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 17.0 | View |
| Lung Adenocarcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 17.0 | View |
| Lymphoproliferative Disorder | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 17.0 | View |
| Oropharyngeal Squamous Cell Carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 17.0 | View |
| Rectal Adenocarcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 17.0 | View |
| Carotid Artery Stenosis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 17.0 | View |
| Cerebrovascular Accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 17.0 | View |
| Diabetic Neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 17.0 | View |
| Lumbar Radiculopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 17.0 | View |
| Transient Ischaemic Attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 17.0 | View |
| Abortion Missed | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA Version 17.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 17.0 | View |
| Mental Status Changes | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 17.0 | View |
| Acute Kidney Injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 17.0 | View |
| Calculus Ureteric | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 17.0 | View |
| Calculus Urinary | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 17.0 | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 17.0 | View |
| Nephrotic Syndrome | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 17.0 | View |
| Renal Colic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 17.0 | View |
| Cervical Dysplasia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 17.0 | View |
| Acute Respiratory Failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.0 | View |
| Interstitial Lung Disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.0 | View |
| Laryngeal Oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.0 | View |
| Oropharyngeal Discomfort | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.0 | View |
| Pleural Effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.0 | View |
| Pulmonary Embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.0 | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 17.0 | View |
| Drug Eruption | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 17.0 | View |
| Skin Ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 17.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 17.0 | View |
| Intermittent Claudication | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 17.0 | View |
| Phlebitis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 17.0 | View |
| Thrombosed Varicose Vein | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 17.0 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 17.0 | View |
| Normochromic Normocytic Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 17.0 | View |
| Pancytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 17.0 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 17.0 | View |
| Acute Coronary Syndrome | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 17.0 | View |
| Angina Unstable | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 17.0 | View |
| Atrial Fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 17.0 | View |
| Atrial Flutter | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 17.0 | View |
| Coronary Artery Disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 17.0 | View |
| Coronary Artery Stenosis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 17.0 | View |
| Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 17.0 | View |
| Goitre | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA Version 17.0 | View |
| Diplopia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 17.0 | View |
| Anal Fissure | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 17.0 | View |
| Diverticular Perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 17.0 | View |
| Diverticulum Intestinal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 17.0 | View |
| Duodenal Ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 17.0 | View |
| Duodenal Ulcer Perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 17.0 | View |
| Faecal Incontinence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 17.0 | View |
| Gastric Ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 17.0 | View |
| Gastric Ulcer Perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 17.0 | View |
| Gastritis Erosive | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 17.0 | View |
| Gastrooesophageal Reflux Disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 17.0 | View |
| Intestinal Obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 17.0 | View |
| Large Intestine Polyp | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 17.0 | View |
| Lower Gastrointestinal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 17.0 | View |
| Pancreatic Pseudocyst | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 17.0 | View |
| Pancreatitis Acute | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 17.0 | View |
| Tongue Ulceration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 17.0 | View |
| Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 17.0 | View |
| Device Dislocation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 17.0 | View |
| Non-Cardiac Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 17.0 | View |
| Sudden Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 17.0 | View |
| Cholecystitis Acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 17.0 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 17.0 | View |
| Abscess Jaw | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Alpha Haemolytic Streptococcal Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Arthritis Infective | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Clostridium Difficile Colitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Colonic Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Diverticulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Empyema | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Escherichia Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Herpes Zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Infectious Pleural Effusion | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Necrotising Fasciitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Osteomyelitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Urosepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Impaired Healing | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 17.0 | View |
| Drug Hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 17.0 | View |
| Food Allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 17.0 | View |
| Abdominal Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Device Related Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Erysipelas | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Peritonitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Wound Infection Pseudomonas | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Femur Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 17.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Blepharitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 17.0 | View |
| Chronic Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 17.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 17.0 | View |
| Injection Site Erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 17.0 | View |
| Injection Site Pruritus | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 17.0 | View |
| Injection Site Swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 17.0 | View |
| Drug-Induced Liver Injury | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 17.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Conjunctivitis Bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 17.0 | View |
| Alanine Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 17.0 | View |
| Aspartate Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 17.0 | View |
| Neutrophil Count Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 17.0 | View |
| White Blood Cell Count Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 17.0 | View |
| X-Ray with Contrast Upper Gastrointestinal Tract Abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 17.0 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 17.0 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | View |
| Muscle Spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | View |
| Rheumatoid Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.0 | View |
| Nasal Pruritus | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.0 | View |
| Eczema Asteatotic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 17.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 17.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 17.0 | View |
| Hepatitis B Dna Assay Positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 17.0 | View |
| Lymphocyte Count Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 17.0 | View |