Adverse Events Module

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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 @ 2:49 AM
Ignite Modification Date: 2025-12-26 @ 1:31 AM
NCT ID: NCT00712933
Description: The MITT consisted of all randomized participants who received at least one dose of trial medication.
Frequency Threshold: 5
Time Frame: On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)
Study: NCT00712933
Study Brief: A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Belimumab 10mg/kg IV Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. 11 None 231 735 614 735 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bacterial pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Bacterial sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 19.1 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Cytomegalovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Lupus vasculitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Endometriosis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.1 View
Vertigo positional SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Lupus nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Urinary tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Raynaud's phenomenon SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
SLE arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Systemic lupus erythematosus rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Abscess soft tissue SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Bronchitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Cervical dysplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.1 View
Cervix carcinoma stage 0 SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Diarrhoea infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.1 View
Escherichia infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Fibromyalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Haemolytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Nephrotic syndrome SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.1 View
Pelvic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Uterine leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Vasculitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Wound infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Abdominal adhesions SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Abdominal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Abscess of salivary gland SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Acinetobacter bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Acinetobacter infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Agranulocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Amoebic dysentery SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Aortic dissection SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Aortic stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Aortic valve sclerosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Atrioventricular block second degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Benign breast neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Benign neoplasm of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Biliary dilatation SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Bladder diverticulum SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Bowen's disease SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Bronchitis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Bursitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Bursitis infective staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Cardiac tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Cellulitis staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Cerebral thrombosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Cholangitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Complication associated with device SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Coronary artery occlusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Craniocerebral injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Cutaneous tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Cyst SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Cystitis haemorrhagic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Duodenitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Dysfunctional uterine bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.1 View
Enterococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Escherichia bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Escherichia sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Extrapyramidal disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Fibula fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Fungaemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Gallbladder non-functioning SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Gastroenteritis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Gastrointestinal fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Gastrointestinal viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Gestational diabetes SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 19.1 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Haemorrhagic disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Haemorrhagic ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.1 View
Haemorrhoidal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Haemothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Hepatitis A SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Herpes zoster cutaneous disseminated SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 19.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 19.1 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Infectious colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Infectious pleural effusion SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Intracranial pressure increased SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Intraductal papilloma of breast SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Invasive ductal breast carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Joint abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Joint tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Kyphosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Lacunar stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Latent tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Lower respiratory tract inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Lupus enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Lupus hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Lupus myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Lupus pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Maculopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.1 View
Mania SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Meningitis aseptic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Myasthenia gravis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Neuropsychiatric lupus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Obesity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Osteochondrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Osteomyelitis chronic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Ovarian cyst ruptured SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.1 View
Ovarian cyst torsion SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Papillary thyroid cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Paraplegia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Parasitic gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Parovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.1 View
Pathological fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Pelvic inflammatory disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pemphigoid SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Pericarditis lupus SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Peripheral artery stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Peritonitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Portal vein thrombosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Post procedural fistula SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Proctitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Pulmonary congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Pulmonary haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Pulmonary mycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pulmonary tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pyoderma gangrenosum SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Rectal adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Rectal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Rectal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Renal tubular acidosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Renal tubular necrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Rhinitis hypertrophic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Salmonella bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Sialoadenitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Skin candida SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Staphylococcal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Streptococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Tendon rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Tension headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Thrombotic thrombocytopenic purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Tracheitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Tubo-ovarian abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Ulna fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Upper respiratory tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Urinary tract infection fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Uterine haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.1 View
Uterine polyp SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.1 View
Varicose vein SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Vulval cancer stage 0 SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Urinary tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Upper respiratory tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Bronchitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Pharyngitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View