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 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 12:47 AM
NCT ID:
NCT00056160
Description:
Analyses of safety (Serious Adverse Events and Other Adverse Events) were based upon the Safety Population (all subjects who were administered at least one dose of study medication) and include all data available.
Frequency Threshold:
5
Time Frame:
Up to 254 weeks (median=48 weeks; mean=77 weeks)
Study:
NCT00056160
Study Brief:
CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo/Dex | Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone | None | None | 90 | 175 | 175 | 175 | View |
| CC-5013/Dex | CC-5013 (lenalidomide) plus oral high-dose dexamethasone | None | None | 111 | 177 | 177 | 177 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| ABSCESS INTESTINAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| ACETABULUM FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (5.1) | View |
| ACUTE MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (5.1) | View |
| ARTERIOSPASM CORONARY | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (5.1) | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| CONFUSIONAL STATE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (5.1) | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| CONVULSIONS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| CORONARY ARTERY DISEASE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (5.1) | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| EMPHYSEMATOUS BULLA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| ENCEPHALITIS HERPES | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| ENTEROBACTER BACTERAEMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| HERPES ZOSTER | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| HIP FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (5.1) | View |
| HYPERAMMONAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (5.1) | View |
| HYPOGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (5.1) | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (5.1) | View |
| HYPOMAGNESAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (5.1) | View |
| LYMPHADENOPATHY | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (5.1) | View |
| MAJOR DEPRESSIVE DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (5.1) | View |
| MENTAL STATUS CHANGES | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (5.1) | View |
| PERIPHERAL ISCHAEMIA | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (5.1) | View |
| SQUAMOUS CELL CARCINOMA OF SKIN | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (5.1) | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| ARTHRITIS BACTERIAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (5.1) | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (5.1) | View |
| ATRIAL FLUTTER | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (5.1) | View |
| AZOTAEMIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (5.1) | View |
| BLINDNESS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (5.1) | View |
| BLINDNESS TRANSIENT | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (5.1) | View |
| BLOOD BILIRUBIN ABNORMAL | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (5.1) | View |
| BLOOD CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (5.1) | View |
| BONE PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | View |
| BRONCHIOLOALVEOLAR CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (5.1) | View |
| BRONCHOSPASM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| CARDIAC ARREST | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (5.1) | View |
| CARDIAC FAILURE CONGESTIVE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (5.1) | View |
| CARDIO-RESPIRATORY ARREST | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (5.1) | View |
| CATARACT UNILATERAL | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (5.1) | View |
| CATHETER RELATED INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| CATHETER SITE PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (5.1) | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| CELLULITIS STAPHYLOCOCCAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| CEREBELLAR INFARCTION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| CEREBRAL INFARCTION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| CEREBRAL ISCHAEMIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| CEREBROVASCULAR ACCIDENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (5.1) | View |
| CHEST WALL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | View |
| CHRONIC OBSTRUCTIVE AIRWAYS DISEASE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| CLOSTRIDIUM COLITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| COLITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| COLITIS PSEUDOMEMBRANOUS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| DEEP VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (5.1) | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (5.1) | View |
| DELIRIUM | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (5.1) | View |
| DELUSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (5.1) | View |
| DEPRESSED LEVEL OF CONSCIOUSNESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| DERMATITIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (5.1) | View |
| DIABETES WITH HYPEROSMOLARITY | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (5.1) | View |
| DIABETIC KETOACIDOSIS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (5.1) | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| DIVERTICULAR PERFORATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| DIVERTICULITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| DIVERTICULUM INTESTINAL HAEMORRHAGIC | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| DYSPNOEA EXACERBATED | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| EPISTAXIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| FANCONI SYNDROME ACQUIRED | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (5.1) | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (5.1) | View |
| FEBRILE NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (5.1) | View |
| FEMUR FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (5.1) | View |
| FIBULA FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (5.1) | View |
| FLUID OVERLOAD | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (5.1) | View |
| GASTRITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| GINGIVAL BLEEDING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| HAEMATURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (5.1) | View |
| HAEMOGLOBIN DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (5.1) | View |
| HAEMORRHOIDAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| HEPATIC FAILURE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (5.1) | View |
| HEPATITIS TOXIC | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (5.1) | View |
| HERPES VIRAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| HYPERCALCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (5.1) | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (5.1) | View |
| HYPERKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (5.1) | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (5.1) | View |
| HYPERTENSIVE CRISIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (5.1) | View |
| HYPERVISCOSITY SYNDROME | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (5.1) | View |
| HYPOALBUMINAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (5.1) | View |
| HYPOCALCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (5.1) | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (5.1) | View |
| HYPOXIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| INGUINAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| INTERNATIONAL NORMALISED RATIO INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (5.1) | View |
| INTERSTITIAL PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| INTESTINAL ISCHAEMIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| INTRACRANIAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| INTRACRANIAL VENOUS SINUS THROMBOSIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| LARGE INTESTINAL PERFORATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| LEUKAEMIA PLASMACYTIC | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (5.1) | View |
| LEUKOENCEPHALOPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| LIVER FUNCTION TESTS ABNORMAL | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (5.1) | View |
| LOBAR PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| LOWER GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| LUNG NODULE | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (5.1) | View |
| METABOLIC ACIDOSIS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (5.1) | View |
| METASTASES TO LIVER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (5.1) | View |
| MULTIPLE FRACTURES | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (5.1) | View |
| MUSCLE WEAKNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | View |
| MYELODYSPLASTIC SYNDROME | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (5.1) | View |
| MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (5.1) | View |
| MYOPATHY STEROID | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (5.1) | View |
| NEUTROPENIC SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (5.1) | View |
| ORTHOSTATIC HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (5.1) | View |
| OSTEOMYELITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| OSTEONECROSIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | View |
| PANCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (5.1) | View |
| PERIPHERAL ISCHAEMIA | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (5.1) | View |
| PLASMACYTOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (5.1) | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| PNEUMOCOCCAL BACTERAEMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| PNEUMOCYSTIS CARINII PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| PNEUMONIA BACTERIAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| PNEUMONIA CYTOMEGALOVIRAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| PNEUMONIA FUNGAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| PNEUMONIA PRIMARY ATYPICAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| PNEUMONIA STAPHYLOCOCCAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| PNEUMONIA STREPTOCOCCAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| PSYCHOTIC DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (5.1) | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| PULMONARY OEDEMA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (5.1) | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (5.1) | View |
| RADIUS FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (5.1) | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (5.1) | View |
| RENAL FAILURE ACUTE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (5.1) | View |
| RENAL FAILURE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (5.1) | View |
| RENAL TUBULAR NECROSIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (5.1) | View |
| RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| RETINAL DETACHMENT | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (5.1) | View |
| RETINAL VEIN OCCLUSION | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (5.1) | View |
| RIB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (5.1) | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| SINUS TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (5.1) | View |
| SINUSITIS FUNGAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| SKIN DESQUAMATION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (5.1) | View |
| SKIN DISCOLOURATION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (5.1) | View |
| SMALL INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| SOMNOLENCE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| SPINAL COMPRESSION FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (5.1) | View |
| SPINAL CORD COMPRESSION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| SQUAMOUS CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (5.1) | View |
| STAPHYLOCOCCAL SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| STREPTOCOCCAL BACTERAEMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| STREPTOCOCCAL SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| SUBACUTE ENDOCARDITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| SUBDURAL HAEMATOMA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| SUICIDE ATTEMPT | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (5.1) | View |
| SUPERIOR VENA CAVAL OCCLUSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (5.1) | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| SYSTEMIC INFLAMMATORY RESPONSE SYNDROME | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (5.1) | View |
| TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (5.1) | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (5.1) | View |
| TOOTH ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| TRANSIENT ISCHAEMIC ATTACK | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| UROSEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| VASCULAR GRAFT OCCLUSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (5.1) | View |
| VIRAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| WHITE BLOOD CELL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (5.1) | View |
| WRIST FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (5.1) | View |
| ADRENAL INSUFFICIENCY | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (5.1) | View |
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (5.1) | View |
| ANAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| ANGINA PECTORIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (5.1) | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (5.1) | View |
| AORTIC STENOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (5.1) | View |
| APPENDICEAL ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| APPENDICITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| ARTERIAL THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (5.1) | View |
| ACQUIRED BRONCHOMALACIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (5.1) | View |
| ANOREXIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (5.1) | View |
| APPETITE DECREASED | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (5.1) | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | View |
| BONE PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| CATARACT | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (5.1) | View |
| CATARACT UNILATERAL | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (5.1) | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (5.1) | View |
| CONFUSIONAL STATE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (5.1) | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| CUSHINGOID | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (5.1) | View |
| DEEP VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (5.1) | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (5.1) | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (5.1) | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| DRY SKIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (5.1) | View |
| DYSGEUSIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| DYSPNOEA EXERTIONAL | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| EPISTAXIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| FACE OEDEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (5.1) | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (5.1) | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (5.1) | View |
| JOINT SWELLING | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | View |
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (5.1) | View |
| LOOSE STOOLS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| MOOD ALTERATION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (5.1) | View |
| MOOD SWINGS | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (5.1) | View |
| MUSCLE WEAKNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | View |
| MUSCULOSKELETAL STIFFNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (5.1) | View |
| NIGHT SWEATS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (5.1) | View |
| NOCTURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (5.1) | View |
| OEDEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (5.1) | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (5.1) | View |
| ORAL CANDIDIASIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| ORAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| PAIN IN LIMB | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (5.1) | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| PERIPHERAL NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| PERIPHERAL SWELLING | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | View |
| PHARYNGITIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| PRODUCTIVE COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (5.1) | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (5.1) | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (5.1) | View |
| RHINORRHOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| RIGORS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (5.1) | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| SOMNOLENCE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| STOMATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| SWEATING INCREASED | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (5.1) | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (5.1) | View |
| TOOTHACHE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| TREMOR | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| URINARY FREQUENCY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (5.1) | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| VISION BLURRED | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (5.1) | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (5.1) | View |
| MUSCLE CRAMP | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | View |
| MUSCLE SPASMS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | View |
| NASAL CONGESTION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| ABDOMINAL DISTENSION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| AGEUSIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (5.1) | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (5.1) | View |
| BALANCE IMPAIRED | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| BLOOD CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (5.1) | View |
| CHEST WALL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | View |
| CONTUSION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (5.1) | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| DRY MOUTH | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| ECCHYMOSIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (5.1) | View |
| ERYTHEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (5.1) | View |
| FLATULENCE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| FLUID RETENTION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (5.1) | View |
| FLUSHING | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (5.1) | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (5.1) | View |
| HERPES SIMPLEX | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (5.1) | View |
| HICCUPS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| HOARSENESS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (5.1) | View |
| HYPERKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (5.1) | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (5.1) | View |
| HYPOCALCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (5.1) | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (5.1) | View |
| HYPOMAGNESAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (5.1) | View |
| HYPOPHOSPHATAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (5.1) | View |
| INFLUENZA LIKE ILLNESS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (5.1) | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (5.1) | View |
| IRRITABILITY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (5.1) | View |
| LETHARGY | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (5.1) | View |
| LIVER FUNCTION TESTS ABNORMAL | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (5.1) | View |