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 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
NCT ID:
NCT01728805
Description:
The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184.
One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.
Frequency Threshold:
5
Time Frame:
All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.
Study:
NCT01728805
Study Brief:
Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| KW-0761 | anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab) KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression | 40 | None | 69 | 184 | 178 | 184 | View |
| Vorinostat | vorinostat 400 mg once daily Vorinostat | 47 | None | 46 | 186 | 182 | 186 | View |
| Vorinostat Original Then Crossover to KW-0761 | Subjects who were randomized to vorinostat could be crossed over to receive mogamulizumab upon disease progression and with permission from the Medical Monitor. | 32 | None | 40 | 135 | 128 | 135 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (20.0) | View |
| Anaemia Haemolytic Autoimmune | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (20.0) | View |
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (20.0) | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| Cardiac Failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| Left Ventricular Hypertrophy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| Myocarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| Supraventricular Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| Ear Pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (20.0) | View |
| Lens Dislocation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (20.0) | View |
| Retinal Vein Occlusion | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (20.0) | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Anal Fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Gastric Haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Gastrointestinal Haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Ileitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Inguinal Hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Intestinal Obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Large Intestinal Ulcer Haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Lip Swelling | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Chest Discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Device Failure | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Disease Progression | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Facial Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| General Physical Health Deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Hypothermia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Localised Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Oedema Peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Autoimmune Hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.0) | View |
| Cholangitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.0) | View |
| Cholecystitis Acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.0) | View |
| Hepatic Failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.0) | View |
| Hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.0) | View |
| Hepatitis Acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.0) | View |
| Hepatocellular Injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.0) | View |
| Contrast Media Allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (20.0) | View |
| Drug Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (20.0) | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (20.0) | View |
| Abscess Limb | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Arthritis Bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Atypical Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Cytomegalovirus Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Device Related Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Endocarditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Enterovirus Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Epstein-Barr Virus Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Herpes Simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Herpes Zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Lower Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Meningitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Otitis Externa | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Periorbital Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Pneumonia Legionella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Pneumonia Pneumococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Postoperative Wound Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Rhinovirus Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Sepsis Syndrome | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Septic Embolus | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Septic Shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Skin Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Staphylococcal Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Staphylococcal Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Staphylococcal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Staphylococcal Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Superinfection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Urinary Tract Infection Bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Viral Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Wound Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| Femur Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| Infusion Related Reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| Lower Limb Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| Pelvic Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| Subdural Haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| Subdural Haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| Vascular Access Complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| Aspartate Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| Blood Alkaline Phospatase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| Blood Creatinine Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| Gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| Metabolic Acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| Monarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| Muscular Weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| Musculoskeletal Chest Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| Myositis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| Polymyositis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| Adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | View |
| Bladder Transitional Cell Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | View |
| Bowen's Disease | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | View |
| Colon Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | View |
| Infected Neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | View |
| Malignant Melanoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | View |
| Malignant Pleural Effusion | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | View |
| Metastases to Lymph Nodes | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | View |
| Mycosis Fungoides | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | View |
| Squamous Cell Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | View |
| Depressed Level of Consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| Haemorrhage Intracranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| Hepatic Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| Metabolic Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| Miller Fisher Syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| Monoparesis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| Motor Dysfunction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| Confusional State | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.0) | View |
| Mental Status Changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.0) | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.0) | View |
| Renal Failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.0) | View |
| Renal Failure Acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.0) | View |
| Renal Impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.0) | View |
| Urinary Retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.0) | View |
| Oedema Genital | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (20.0) | View |
| Acute Respiratory Distress Syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| Bronchitis Chronic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| Chronic Obstructive Pulmonary Disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| Dyspnoea Exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| Interstitial Lung Disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| Pleural Effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| Dermatitis Exfoliative | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| Drug Eruption | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| Photosensitivity Reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| Pruritis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| Skin Disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| Social Stay Hospitalization | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA (20.0) | View |
| Cardiac Pacemaker Replacement | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (20.0) | View |
| Air Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.0) | View |
| Aortic Stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.0) | View |
| Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.0) | View |
| Peripheral Arterial Occlusive Disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.0) | View |
| Phlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.0) | View |
| Haemolytic Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (20.0) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (20.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (20.0) | View |
| Acute Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| Angina Pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| Angina Unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| Bronchopneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Pneumocystis Jiroveci Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Pneumonia Influenzal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Basal Cell Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | View |
| Ovarian Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (20.0) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (20.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (20.0) | View |
| Dry Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (20.0) | View |
| Vision Blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (20.0) | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Oedema Peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Oral Candidasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Skin Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| Infusion Related Reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| Aspartate Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| Blood Creatinine Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| Platelet Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| Weight Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| Weight Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| Muscle Spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| Muscular Weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| Pain In Extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| Oropharyngeal Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| Drug Eruption | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| Intertrigo | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |