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 @ 5:04 PM
Ignite Modification Date:
2025-12-25 @ 2:43 PM
NCT ID:
NCT00264550
Description:
All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.
Frequency Threshold:
5
Time Frame:
Adverse event data were collected for 5 years
Study:
NCT00264550
Study Brief:
An Efficacy and Safety Study of Golimumab 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 |
|---|---|---|---|---|---|---|---|---|
| Group 1: Golimumab 50 mg SC Injections Only | Participants who were treated with golimumab and received golimumab 50 mg injections only during the study. Participants also received methotrexate capsules throughout the study. | None | None | 33 | 105 | 96 | 105 | View |
| Group 2: Golimumab 100 mg SC Injections Only | Participants who were treated with golimumab and received golimumab 100 mg injections only during the study. Participants also received either methotrexate or placebo capsules throughout the study. | None | None | 84 | 184 | 160 | 184 | View |
| Group 3: Golimumab 50 and 100 mg SC Injections | Participants who were treated with golimumab and received at least one injection of both golimumab 50 mg and golimumab 100 mg during the study. Participants also received either methotrexate or placebo capsules throughout the study. | None | None | 55 | 145 | 118 | 145 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 15.0 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 15.0 | View |
| Acute Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 15.0 | View |
| Angina Unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 15.0 | View |
| Arteriosclerosis Coronary Artery | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 15.0 | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 15.0 | View |
| Atrioventricular Block | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 15.0 | View |
| Cardiac Failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 15.0 | View |
| Cardiovascular Insufficiency | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 15.0 | View |
| Congestive Cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 15.0 | View |
| Coronary Artery Disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 15.0 | View |
| Cyanosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 15.0 | View |
| Dressler's Syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 15.0 | View |
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 15.0 | View |
| Myocardial Ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 15.0 | View |
| Supraventricular Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 15.0 | View |
| Deafness Neurosensory | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 15.0 | View |
| Goitre | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA Version 15.0 | View |
| Retinal Detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.0 | View |
| Scleritis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.0 | View |
| Scotoma | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.0 | View |
| Diverticulum Intestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.0 | View |
| Duodenal Ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.0 | View |
| Gastric Ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.0 | View |
| Gastrointestinal Haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.0 | View |
| Gastrooesophageal Reflux Disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.0 | View |
| Inguinal Hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.0 | View |
| Oesophagitis Ulcerative | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.0 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.0 | View |
| Pancreatitis Acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.0 | View |
| Parotid Gland Enlargement | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.0 | View |
| Small Intestinal Obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.0 | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.0 | View |
| Necrosis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.0 | View |
| Acute Hepatic Failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 15.0 | View |
| Biliary Colic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 15.0 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 15.0 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 15.0 | View |
| Hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 15.0 | View |
| Anti-Neutrophil Cytoplasmic Antibody Positive Vasculitis | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 15.0 | View |
| Sarcoidosis | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 15.0 | View |
| Abscess Limb | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Arthritis Bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Chronic Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Chronic Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Disseminated Tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Empyema | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Lower Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Mastoiditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Otitis Externa | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Peritoneal Tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Pneumonia Primary Atypical | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Postoperative Wound Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Pulmonary Tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Pyelonephritis Acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Septic Arthritis Staphylococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Septic Shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Subcutaneous Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Tuberculous Pleurisy | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Vulval Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Abdominal Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.0 | View |
| Ankle Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.0 | View |
| Brain Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.0 | View |
| Clavicle Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.0 | View |
| Craniocerebral Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.0 | View |
| Femoral Neck Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.0 | View |
| Femur Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.0 | View |
| Foot Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.0 | View |
| Hand Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.0 | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.0 | View |
| Ligament Sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.0 | View |
| Limb Crushing Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.0 | View |
| Lumbar Vertebral Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.0 | View |
| Postpericardiotomy Syndrome | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.0 | View |
| Spinal Column Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.0 | View |
| Tendon Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.0 | View |
| Tendon Rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.0 | View |
| Tibia Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.0 | View |
| Upper Limb Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.0 | View |
| Wrist Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.0 | View |
| Weight Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.0 | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 15.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | View |
| Arthropathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | View |
| Bone Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | View |
| Lumbar Spinal Stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | View |
| Rheumatoid Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | View |
| Rheumatoid Nodule | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | View |
| Scoliosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | View |
| Soft Tissue Necrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | View |
| Spinal Column Stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | View |
| Spondylolisthesis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | View |
| Synovitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | View |
| Basal Cell Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | View |
| Bowen's Disease | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | View |
| Breast Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | View |
| Breast Cancer in Situ | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | View |
| Bronchial Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | View |
| Lung Neoplasm Malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | View |
| Lymphoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | View |
| Lymphoproliferative Disorder | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | View |
| Malignant Melanoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | View |
| Neuroma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | View |
| Prostate Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | View |
| Squamous Cell Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | View |
| Thyroid Adenoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | View |
| Thyroid Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | View |
| Uterine Leiomyoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | View |
| Axonal Neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 15.0 | View |
| Carotid Artery Stenosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 15.0 | View |
| Cerebrovascular Accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 15.0 | View |
| Paresis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 15.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 15.0 | View |
| Suicide Attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 15.0 | View |
| Calculus Urinary | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 15.0 | View |
| Incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 15.0 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 15.0 | View |
| Nephrotic Syndrome | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 15.0 | View |
| Renal Failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 15.0 | View |
| Stress Urinary Incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 15.0 | View |
| Breast Calcifications | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 15.0 | View |
| Breast Enlargement | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 15.0 | View |
| Cystocele | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 15.0 | View |
| Dysfunctional Uterine Bleeding | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 15.0 | View |
| Endometriosis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 15.0 | View |
| Uterine Prolapse | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 15.0 | View |
| Acute Pulmonary Oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | View |
| Chronic Obstructive Pulmonary Disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | View |
| Haemothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | View |
| Interstitial Lung Disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | View |
| Lung Disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | View |
| Obstructive Airways Disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | View |
| Pleurisy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | View |
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | View |
| Respiratory Distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | View |
| Vocal Cord Disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | View |
| Vocal Cord Polyp | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | View |
| Decubitus Ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | View |
| Deep Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 15.0 | View |
| Hypertensive Emergency | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 15.0 | View |
| Venous Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 15.0 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.0 | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.0 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.0 | View |
| Arthritis Infective | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Hepatitis E | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Herpes Zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Incision Site Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Lobar Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Limb Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.0 | View |
| Bunion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | View |
| Chondropathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | View |
| Foot Deformity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | View |
| Intervertebral Disc Protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | View |
| Joint Destruction | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | View |
| Endometrial Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | View |
| Gastric Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | View |
| Haemangioma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | View |
| Lung Adenocarcinoma Metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 15.0 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 15.0 | View |
| Lumbar Radiculopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 15.0 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 15.0 | View |
| Menopausal Symptoms | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 15.0 | View |
| Menorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 15.0 | View |
| Pelvic Adhesions | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 15.0 | View |
| Nasal Septum Disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | View |
| Drug Eruption | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Oral Herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.0 | View |
| Aspartate Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.0 | View |
| Hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 15.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | View |
| Musculoskeletal Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | View |
| Osteoporosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | View |
| Pain in Extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 15.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | View |
| Oropharyngeal Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | View |
| Productive Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | View |
| Upper Respiratory Tract Congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 15.0 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.0 | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.0 | View |
| Herpes Zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.0 | View |
| Rheumatoid Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 15.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 15.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | View |
| Skin Lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 15.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.0 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.0 | View |
| Gastrooesophageal Reflux Disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.0 | View |
| Injection Site Erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.0 | View |
| Oedema Peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Fungal Skin Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.0 | View |