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 @ 2:44 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
NCT ID:
NCT00082433
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00082433
Study Brief:
Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| HYPOTHERMIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| SUDDEN DEATH | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| EXTRAVASATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| CATHETER THROMBOSIS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| MULTI-ORGAN FAILURE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| VENOUS THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.1 | View |
| DEEP VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.1 | View |
| INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| ERYSIPELAS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| MENINGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| PARONYCHIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| ABSCESS LIMB | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| CONVULSION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| MONOPLEGIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| SOMNOLENCE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| HEMIPARESIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| HYPOAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| ENCEPHALOPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| POLYNEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| PANCREATIC CYST | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| MOUTH ULCERATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| GASTRITIS EROSIVE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| GASTROINTESTINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| UPPER GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| VERTIGO | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 10.1 | View |
| PROTHROMBIN TIME PROLONGED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| VENOUS THROMBOSIS LIMB | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.1 | View |
| JUGULAR VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.1 | View |
| CEREBRAL ISCHAEMIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| AUTONOMIC NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| GASTROINTESTINAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| INCISIONAL HERNIA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| LOWER LIMB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| SKIN EXFOLIATION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| SKIN DISCOLOURATION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| DERMATITIS EXFOLIATIVE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| STEVENS-JOHNSON SYNDROME | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| VAGINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 10.1 | View |
| FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| OVERDOSE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| DRUG TOXICITY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| ANKLE FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| FEMUR FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| TIBIA FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| WRIST FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| FIBULA FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| PELVIC FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| PUBIC RAMI FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| TRACHEAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| TRANSFUSION REACTION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| FEMORAL NECK FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| PROCEDURAL COMPLICATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| LUMBAR VERTEBRAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| BONE PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| FLANK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| MUSCULOSKELETAL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| PATHOLOGICAL FRACTURE | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| MUSCULOSKELETAL CHEST PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| SYSTEMIC LUPUS ERYTHEMATOSUS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| HYPOXIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| EPISTAXIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| ALVEOLITIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| PNEUMONITIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| PNEUMOTHORAX | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| LUNG DISORDER | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| PLEURITIC PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| PULMONARY OEDEMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| ACUTE RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| ACUTE RESPIRATORY DISTRESS SYNDROME | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| CATHETER SITE OEDEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| MUCOSAL INFLAMMATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| INJECTION SITE EXTRAVASATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| PERFORMANCE STATUS DECREASED | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| GENERAL PHYSICAL HEALTH DETERIORATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| TUMOUR PAIN | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | View |
| COLON CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | View |
| BREAST CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | View |
| BREAST NEOPLASM | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | View |
| MALIGNANT ASCITES | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | View |
| MALIGNANT MELANOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | View |
| METASTASES TO BONE | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | View |
| METASTASES TO LUNG | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | View |
| BREAST CANCER METASTATIC | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | View |
| MALIGNANT PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | View |
| MALIGNANT NEOPLASM PROGRESSION | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | View |
| PERICARDIAL EFFUSION MALIGNANT | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | View |
| METASTASES TO CENTRAL NERVOUS SYSTEM | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | View |
| EYE PAIN | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 10.1 | View |
| ECTROPION | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 10.1 | View |
| EYELID PTOSIS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 10.1 | View |
| VISUAL DISTURBANCE | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 10.1 | View |
| BLINDNESS UNILATERAL | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 10.1 | View |
| ULCERATIVE KERATITIS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 10.1 | View |
| DIAGNOSTIC PROCEDURE | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| HAEMOGLOBIN DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| BLOOD ALBUMIN DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| PLATELET COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| BLOOD PHOSPHORUS INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| NEUTROPHIL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| WHITE BLOOD CELL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| PERICARDITIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| ANGINA UNSTABLE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| CARDIAC FAILURE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| SINUS TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| PERICARDIAL EFFUSION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| ACUTE CORONARY SYNDROME | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| CARDIO-RESPIRATORY ARREST | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| VENTRICULAR EXTRASYSTOLES | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| CARDIAC FAILURE CONGESTIVE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| SHOCK | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.1 | View |
| PHLEBITIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.1 | View |
| THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.1 | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.1 | View |
| LYMPHOEDEMA | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.1 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.1 | View |
| THROMBOPHLEBITIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.1 | View |
| DEPRESSED MOOD | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.1 | View |
| CONFUSIONAL STATE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.1 | View |
| CHOLANGITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 10.1 | View |
| HEPATIC PAIN | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 10.1 | View |
| CHOLELITHIASIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 10.1 | View |
| HEPATIC FAILURE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 10.1 | View |
| CHOLECYSTITIS ACUTE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 10.1 | View |
| HYPERBILIRUBINAEMIA | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 10.1 | View |
| PORTAL VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 10.1 | View |
| HYPERSENSITIVITY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 10.1 | View |
| ATAXIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| DYSTONIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| EPILEPSY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| NEURALGIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| TRANSIENT ISCHAEMIC ATTACK | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| PERIPHERAL MOTOR NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| DEMYELINATING POLYNEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| PERIPHERAL SENSORY NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| DEPRESSED LEVEL OF CONSCIOUSNESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| ILEUS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| ASCITES | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| COLITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| GASTRITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| STOMATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| HAEMORRHOIDS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| OESOPHAGITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| EMPYEMA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| CYSTITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| LYMPHANGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| SEPTIC SHOCK | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| TUBERCULOSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| FUNGAL SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| NAIL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| LOBAR PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| WOUND INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| BRONCHOPNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| NEUTROPENIC SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| VAGINAL CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| ABDOMINAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| ANORECTAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| BACTERIAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| LOCALISED INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| NEUTROPENIC INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| PNEUMONIA STREPTOCOCCAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| CATHETER RELATED INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| GASTROENTERITIS NORWALK VIRUS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| LOWER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| DYSURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 10.1 | View |
| OLIGURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 10.1 | View |
| RENAL ATROPHY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 10.1 | View |
| RENAL FAILURE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 10.1 | View |
| HYDRONEPHROSIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 10.1 | View |
| RENAL FAILURE ACUTE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 10.1 | View |
| CYSTITIS HAEMORRHAGIC | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 10.1 | View |
| CATHETER PLACEMENT | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 10.1 | View |
| CENTRAL VENOUS CATHETERISATION | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 10.1 | View |
| ANOREXIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| HYPERKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| HYPOGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| HYPERCALCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| LYMPH NODE PAIN | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| FEBRILE NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| BLISTER | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| PURPURA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| ERYTHEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| DERMATITIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| SKIN ULCER | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| SKIN LESION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| NAIL DISORDER | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| SKIN REACTION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| SWELLING FACE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| EXFOLIATIVE RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| WEIGHT INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| HAEMOGLOBIN DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| PLATELET COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| NEUTROPHIL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| WHITE BLOOD CELL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.1 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| DYSGEUSIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| HYPOREFLEXIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| NEUROPATHY PERIPHERAL | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| PERIPHERAL MOTOR NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| PERIPHERAL SENSORY NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| STOMATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| ANOREXIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| ALOPECIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| DRY SKIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| ERYTHEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| NAIL DISORDER | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| SKIN HYPERPIGMENTATION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| BONE PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| MUSCULAR WEAKNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| MUSCULOSKELETAL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| MUCOSAL INFLAMMATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |